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November 18, 2016 OrthoSpineNews

TÜBINGEN & TUTTLINGEN, Germany–(BUSINESS WIRE)–SHS Gesellschaft für Beteiligungsmanagement mbH is investing in EIT Emerging Implant Technologies GmbH. EIT was established in Tuttlingen, Germany in 2014 and manufactures spinal implant cages using 3D printing technology. SHS is investing funds from its fourth fund generation to finance EIT’s international growth and development of its innovative products.

3D printing, which is also known as additive manufacturing, is used to manufacture cellular and porous implants of biocompatible titanium. These implants mimic the structure and stiffness of natural bone material more accurately than implants manufactured using traditional methods. This in turn promotes bone ingrowth following fusion operations to achieve better clinical results and reduce complication rates. In addition to this, the implants can be fitted on a patient-specific basis, which serves to increase the contact surface and reduce future risks.

“Our EIT Cellular Titanium implants provide the answer to current challenges in implant design and choice of materials as well the extreme cost pressure in medical technology. The additive manufacturing technology allows us to tackle existing problems with new solutions. Thus we can improve the benefits for patients without increasing costs, which is a clear competitive advantage”, explains Guntmar Eisen, founder and CEO of EIT. “This ensures a high level of patient satisfaction and excellent clinical results. We are looking forward to pushing ahead with our international growth, especially in the United States, and our product development with our new partner SHS.”

“EIT’s 3D-printed spine implants have already proven their superior functionality many times in practical applications, thus promoting EIT’s growth”, adds Dr. Bernhard Schirmers, Managing Partner at SHS Gesellschaft für Beteiligungsmanagement. “EIT Emerging Implant Technologies’ management team is experienced and successful in the field of spine surgery. As a medical technology investor, we look forward to supporting them on their path to increased growth.”

“With SHS, EIT is gaining a shareholder with extensive experience in this industry. Together we can enter the next stage of EIT’s growth. This includes development of the company’s innovative product portfolio as well as entering new countries”, says Guy Selbherr, Managing Director of MBG Mittelständische Beteiligungsgesellschaft Baden-Württemberg.

With a total volume of 125 million euro, the fourth SHS fund is focusing on expansion financing, changes in shareholder structures and successor situations. The Tübingen based investor is planning further acquisitions and investments in the fast-growing medical technology and life-science industries in Germany, Austria and Switzerland in the months ahead.

About EIT Emerging Implant Technologies GmbH:

EIT is the first medical device manufacturer in the orthopedic field to exclusively focus on implants that are designed and produced with additive manufacturing methods.

EIT pushes the boundaries of traditional implant manufacturing to obtain versatile, anatomically designed porous implants with increased functionality and maximal bone ingrowth capabilities for all spinal segments.

The EIT implants made of EIT Cellular Titanium® address the shortcomings of the current designs and materials, thereby ensuring optimal clinical outcomes and maximum patient satisfaction.

EIT provides a complete spinal fusion cage portfolio. Patient specific implants to help in the treatment of complex spinal disorders as well as other interesting implant concepts are in development.

EIT consists of a team of skilled and dedicated professionals with a diverse background in management, research and development and quality assurance. The team has a proven track record setting up and managing innovative spinal implant companies, and has developed an extensive network of contacts over many years including internationally renowned surgeons and opinion leaders in the field of spine surgery.

For further information, visit www.eit-spine.de/

About SHS Gesellschaft für Beteiligungsmanagement mbH

SHS Gesellschaft für Beteiligungsmanagement is based in Tübingen, Germany and invests in medical technology and life science companies with a focus on expansion financing, changes in shareholder structures and successor situations. SHS holds minority as well as majority interests. SHS was founded in 1993 and has since gained extensive experience as industry investor, which supports the growth of its portfolio companies through a network of partnerships regarding the introduction of new products, regulatory issues or entering new markets. The SHS fund’s German and international investors include about the European Investment Fund, professional pension insurers, retirement funds, funds of funds, family offices, entrepreneurs and the SHS management team. The AIFM-registered company is currently investing from its fourth generation of funds, for which investors have provided 125 million euro. Equity of up to 20 million euro is invested. Transactions can be carried out in the mid double-digit million range together with a network of co-investors. Reinhilde Spatscheck, Dr. Bernhard Schirmers, Hubertus Leonhardt and Uwe Steinbacher are the Managing Partners at SHS.

Further information: www.shs-capital.eu


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November 18, 2016 OrthoSpineNews

WESTMINSTER, Colo., Nov. 18, 2016 /PRNewswire/ — Cerapedics, a privately-held orthobiologics company, today announced it has received a Best New Technology Award for spine care as part of the 2016 Orthopedics This Week Spine Technology Awards. The award recognizes the company’s i-FACTOR™ Peptide Enhanced Bone Graft, the first bone graft to be approved for use in the cervical spine by the U.S. Food and Drug Administration (FDA WESTMINSTER). Award winners were announced in conjunction with the 2016 North American Spine Society (NASS) Annual Meeting, held October 26-29 in Boston, MA.

“Over the past year we have been focused on accelerating our commercialization efforts in the U.S. following the FDA Premarket Approval (PMA) of i-FACTOR Bone Graft,” said Glen Kashuba, CEO of Cerapedics. “We continue to receive outstanding feedback from surgeons across the country who are excited to have a safe, clinically effective and cost effective bone graft that is supported by Level I human data. We are grateful to be recognized by Orthopedics This Week and the surgeon panel who chose i-FACTOR Bone Graft for the Best New Technology Award.”

i‐FACTOR Bone Graft is based on synthetic small peptide (P-15) technology developed by Cerapedics to support bone growth through cell attachment and activation. In November 2015, i-FACTOR Bone Graft was approved by the FDA for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease.

The annual Orthopedics This Week Spine Technology Awards honor inventors, engineering teams, surgeons and their companies who have created the most innovative, enduring and practical products to treat back pain. For more information, visit https://ryortho.com/2016/11/the-ten-best-new-spine-technologies-for-2016/.

About Cerapedics

Cerapedics is an orthobiologics company focused on developing and commercializing its proprietary synthetic small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safer and more predictable bone formation compared to commercially available bone growth factors. More information can be found at www.cerapedics.com.

Media contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com

 

SOURCE Cerapedics

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November 18, 2016 OrthoSpineNews

Global medical technology company Medtronic has started construction of its new distribution facility in Heerlen, the Netherlands. Located next to the company’s existing Center of Excellence, the 355,200-square-foot facility will begin operations in 2017. It will support the creation of 140 new jobs in addition to the existing 1,000 jobs Medtronic has in Heerlen. Medtronic will use the facility to store and distribute medical devices like implants, surgical instruments and patient monitoring systems.

Distribution Growth

Heerlen’s central location and logistics infrastructure will improve Medtronic’s distribution. Medtronic will work closely with global supply chain management company CEVA Logistics to reach more than 15,000 European hospitals and clinics within 24 hours.

“We strive to ensure the timely delivery of our medical technology products to hospitals and patients, and the unique geographical location of this new facility is aimed at supporting anticipated growth across the European market. We look forward to enhancing our presence in this community,” said Sikko Zoer, Vice President of Customer and Supply Chain at Medtronic EMEA (Europe, Middle East and Africa).

South Limburg’s Medical Logistics Cluster

The Dutch province of Limburg, specifically the city of Heerlen, is becoming a hub for medical logistical activities. Companies benefit from similar operations in the region and government support.

“The city of Heerlen offers tremendous opportunities for companies in the medical logistical sector. This investment, in close cooperation with WDP and CEVA Logistics, is a key indicator of growth in the existing medical logistical cluster in the region, highlighting Medtronic’s status as the largest commercial employer in the region,” said Martin de Beer, Alderman Economic Affairs of the Municipality of Heerlen.

Source: CEVA Logistics

November 15, 2016

16 November 2016


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November 18, 2016 OrthoSpineNews

November 16, 2016

EOS imaging has received FDA 510(k) clearance for its knee EOS 3D surgical planning software for total knee arthroplasty, which means the company can now market the software in the United States.

Leveraging weight-bearing 3D images and data from the EOS system, the online 3D planning software can provide an optimized surgical plan for total knee arthroplasty. The software facilitates surgical preparation and alignment in 3D while illustrating relevant clinical parameters in real time, and that generates an initial proposal for the size selection and position of the implant components.

“The knee EOS FDA clearance is an important milestone that allows us to offer our full set of software solutions to the U.S. market,” says Marie Meynadier, EOS imaging’s CEO. Explaining further, she says the solution will support the growing adoption of EOS images, 3D models, and patient-specific datasets throughout the care continuum.

For patients, this means personalized treatments, absent the high dose and cost associated with CT imaging.

For more information about this software, visit EOS imaging.


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November 18, 2016 OrthoSpineNews

By Kelcee Griffis

Law360, New York (November 14, 2016, 8:58 PM EST) — Medtronic Inc. must pay $20.3 million in damages to a doctor who sued the medical device company for patent infringement, a Texas jury decided Friday.

The jury found Medtronic “actively induced” infringement on both of the patents in question held by Mark A. Barry, a doctor who sued the company in 2014 for allegedly infringing on his devices that align vertebrae in patients with conditions such as scoliosis.

The patents cover hardware such as specialized screws and a method of implanting them by surgeons to correct certain spinal deformities.

Barry said Medtronic reproduced and sold implants that compete with his own across the U.S. and internationally. In a motion for judgment as a matter of law filed toward the end of the trial Thursday, the company fired back, saying that there was no way to prove surgeons relied on that highly specific set of screws and tools to complete the surgery.

The jury disagreed, awarding $17.6 million for infringement that occurred within the U.S. and the rest for infringement that took place outside the country.

The trial began Nov. 3 and wrapped up Nov. 11, said Sean P. DeBruine of Kilpatrick Townsend & Stockton LLP, the lead attorney representing Barry. The 10 jurors deliberated for about five hours before coming to a unanimous verdict, he said.

DeBruine said the jury was admirable for spending the Veteran’s Day holiday deciding on the verdict.

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November 18, 2016 OrthoSpineNews

BELGRADE, Mont., Nov. 17, 2016 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development, manufacturing and marketing of orthopedic products for domestic and international markets, announced today the closing of its rights offering (the “Offering”) of units at a subscription price of $0.75 per unit, for aggregate gross proceeds to the Company of approximately $3.8 million.

Pursuant to the Rights Offering, Xtant sold an aggregate of 5,055,345 units consisting of a total of 5,055,345 shares of common stock and 5,055,345 warrants, with each warrant exercisable to purchase one share of common stock an exercise price of $0.90 for five years from the date of issuance. The warrants are anticipated to commence trading on the OTCBB under the symbol “XTNTW” as early as Wednesday, November 23, 2016.

Maxim Group LLC acted as sole dealer manager for the Offering.

If you have questions about the offering, please contact Maxim Group LLC, 405 Lexington Avenue, New York, NY 10174, Attention: Syndicate Department, email: syndicate@maximgrp.com or telephone 212-895-3745.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Xtant Medical’s registration statement on Form S-1 was declared effective by the U.S. Securities and Exchange Commission (SEC) on October 31, 2016. The final prospectus, prospectus supplement no. 1 thereto dated November 9, 2016, and all of Xtant Medical’s SEC filings may be found on the SEC’s website at http://www.sec.gov.

About Xtant Medical Holdings

Xtant Medical Holdings, Inc. (NYSE MKT:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof.

Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: our ability to integrate the acquisition of X-spine Systems, Inc. and any other business combinations or acquisitions successfully; our ability to remain listed on the NYSE MKT; our ability to obtain financing on reasonable terms; our ability to increase revenue; our ability to comply with the covenants in our credit facility; our ability to maintain sufficient liquidity to fund our operations; the ability of our sales force to achieve expected results; our ability to remain competitive; government regulations; our ability to innovate and develop new products; our ability to obtain donor cadavers for our products; our ability to engage and retain qualified technical personnel and members of our management team; the availability of our facilities; government and third-party coverage and reimbursement for our products; our ability to obtain regulatory approvals; our ability to successfully integrate recent and future business combinations or acquisitions; our ability to use our net operating loss carry-forwards to offset future taxable income; our ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; our ability to service our debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; our ability to obtain and protect our intellectual property and proprietary rights; infringement and ownership of intellectual property; our ability to remain accredited with the American Association of Tissue Banks; influence by our management; our ability to pay dividends; our ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” You should carefully consider the trends, risks and uncertainties described in this document, the Form 10-K and other reports filed with or furnished to the SEC before making any investment decision with respect to our securities. If any of these trends, risks or uncertainties actually occurs or continues, our business, financial condition or operating results could be materially adversely affected, the trading prices of our securities could decline, and you could lose all or part of your investment. The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by this cautionary statement.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
xtant@cg.capital

Company Contact
Xtant MedicalMolly Mason
mmason@xtantmedical.com

Source: Xtant Medical Holdings, Inc.

 

 


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November 17, 2016 OrthoSpineNews

WARSAW, Ind., Nov. 17, 2016 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced the launch of the Comprehensive® Vault Reconstruction System (VRS), the first patient-matched glenoid implant cleared to specifically treat patients with a severely deficient rotator cuff and extensive bone loss which precludes the use of a standard glenoid baseplate. The VRS uses CT imaging and advanced 3D reconstruction techniques to allow surgeons to personalize each patient’s implant.

“The treatment options for extensive glenoid deficiencies were limited to bone grafting or hemi-arthroplasties, both of which were unreliable and had marginal success,” said Dr. David Dines, Orthopedic Surgeon at the Hospital for Special Surgery in New York and Professor of Orthopedic Surgery at Weill Cornell Medical College.  “The Comprehensive Vault Reconstruction System represents an important advance in shoulder reconstruction by streamlining and personalizing the implant procedure in hope of more predictable outcomes and results that extend beyond pain relief, to restoring function and improving overall quality of life.”

The first implantation of the VRS took place on September 21, 2016, at the University of Virginia Hospital in Charlottesville, Va. and was successfully performed by Dr. Stephen Brockmeier.

“The Comprehensive Vault Reconstruction System is another example of our commitment to addressing the clinical and unmet needs of shoulder specialists,” said Orsa Britton, Vice President and General Manager of Zimmer Biomet’s global Extremities business. “This innovative, patient-specific implant, coupled with extensive pre-operative planning software, will expand viable treatment options for patients with severe glenoid deformities.”

About Zimmer Biomet

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Cautionary Statement Regarding Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements include, but are not limited to, statements concerning Zimmer Biomet’s expectations, plans, prospects, and product and service offerings, including new product launches and potential clinical successes.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  For a list and description of some of such risks and uncertainties, see our periodic reports filed with the SEC.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in Zimmer Biomet’s filings with the SEC.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Accordingly, such forward-looking statements speak only as of the date made.  Readers of this news release are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this news release.

Logo – http://photos.prnewswire.com/prnh/20150624/225371LOGO

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com


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November 17, 2016 OrthoSpineNews

November 17, 2016

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced that President and Chief Executive Officer Brad Mason will present at the Piper Jaffray Healthcare Conference on Wednesday, November 30, 2016 at 9:10 a.m. Eastern Time in New York, NY.

A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, TX, the company has four strategic business units that include BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the company’s sales representatives, distributors and subsidiaries. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
Investor Relations
markquick@orthofix.com
or
Denise Landry, 214-937-2529
Media Relations
deniselandry@orthofix.com


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November 17, 2016 OrthoSpineNews

SHELTON, CT–(Marketwired – November 17, 2016) – Spine Wave, Inc. is committed to the commercialization of high-quality, innovative medical devices for the treatment of spinal disorders. Spine Wave is pleased to announce that Chief Executive Officer Mark LoGuidice will present at the upcoming 28th Annual Piper Jaffray Healthcare Conference in New York City. The presentation will begin at 4:10 p.m. on Tuesday, November 29th in the Kennedy 1 Room at the Lotte New York Palace.

Mr. LoGuidice’s presentation will highlight Spine Wave’s recent commercial success with new expandable interbody product introductions, as well as provide a glimpse into the 2017 pipeline which will significantly expand both the company’s product portfolio and the addressable market segments.

About Spine Wave

Spine Wave’s vision is to leverage our intellectual property portfolio and engineering expertise to deliver a steady stream of highly differentiated spinal technologies with a particular emphasis on expandable interbody devices. Spine Wave’s portfolio of expandable products now includes the Velocity® Interbody Device, the Leva® Interbody Device and the StaXx® family of products, of which over 50,000 devices have been implanted. Other novel products in the portfolio include the Annex® Adjacent Level System, the Sniper® Spine System, which has developed a reputation as a leading MIS screw system, and the recently acquired True Position® Pivoting Spacer System which is comprised of a “crescent-style” interbody device and a unique delivery mechanism which simplifies accurate and reproducible placement of the implant. Spine Wave is committed to delivering a robust pipeline in 2017 that will allow the company to address every major spine market segment with a highly differentiated offering.

For further information on all of the Spine Wave products please visit the Company’s website at www.SpineWave.com.

CONTACT INFORMATION

  • Contact:
    Terry Brennan
    Chief Financial Officer
    Email contact
    203-712-1810


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November 17, 2016 OrthoSpineNews

Posted in Regulatory and Compliance by MDDI Staff on November 15, 2016

On September 20–21, 2016, FDA convened an advisory panel to seek recommendations about the regulatory classification for wound dressings containing drugs. These devices are widely used to treat medical conditions ranging from minor cuts and burns, to diabetic foot ulcers and historically have been cleared by FDA through the 510(k) process. While this is not the first time FDA has looked to experts to help evaluate the classification of wound dressings containing drugs, this panel meeting was prompted in part by evolutions in technology, the breadth of cleared indications for use, the extensive list of ingredients (many with known or potential chemical activity), and the public health implications associated with antimicrobial resistance (as evidenced by FDA’s recent ban of 19 antibacterial agents in soaps).

The panel’s main focus was on dressings containing antimicrobial drugs, but certain single entity dressings containing materials that are not antimicrobial drugs or preservatives, but that act solely within the dressing to enhance its barrier properties, were also discussed. The panel discussion was largely consistent with FDA’s historical regulatory approach for devices containing drugs, but also highlighted that these products present unique regulatory challenges and public health concerns.

A critical point of discussion involved the differentiation of these products based on the purpose of the drug and how such differences could lead to different regulatory pathways. The use of antimicrobial agents that could lead to increased antimicrobial resistance or toxicity also was a focal point of the discussion and was of particular interest to the panel members. The panel believed that increased scrutiny and regulation may be necessary for some of these products to prevent or limit future increases in antimicrobial resistance.

FDA’s Regulatory Framework and Antimicrobial Resistance Concerns

Antimicrobial agents, which are commonly used to treat, manage, and prevent infectious diseases, come in many forms, all of which are expected to kill or inhibit the growth of microorganisms including bacteria, viruses, fungi, and parasites. Antimicrobials have been added to a variety of medical devices to reduce the risk of infections, including through the prevention of microbial growth on the device itself.

FDA frequently views the addition of an antimicrobial agent to increase the risks associated with a medical device. Many Class I, 510(k)-exempt devices, including hydrogel wound dressings and mattress covers for medical purposes, for example, require 510(k) clearance when an antimicrobial agent is added. FDA generally considers the addition of these agents to change the fundamental scientific technology of the device, thus exceeding the limitations of their 510(k) exemptions.

 

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