ATLAS WOUND MATRIX

K090954 · Wrightmedicaltechnologyinc · KGN · Jul 30, 2009 · SU

Device Facts

• Record ID: K090954
• Device Name: ATLAS WOUND MATRIX
• Applicant: Wrightmedicaltechnologyinc
• Product Code: KGN · SU
• Decision Date: Jul 30, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The ATLAS Wound Matrix devices intended use is for the management of wounds including: partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), draining wounds. The device is supplied sterile and is intended for one-time use.

Device Story

ATLAS Wound Matrix is a sterile, decellularized porcine collagen dermal material used as a wound dressing. It is provided in fenestrated or non-fenestrated forms and is rehydrated at the time of implantation. The matrix is designed to be thin and conformable to various wound geometries. It functions by providing a scaffold environment that supports natural wound healing processes. The device is intended for one-time use in clinical settings for the management of diverse wound types, including chronic ulcers and surgical or trauma-related wounds.

Clinical Evidence

No clinical data provided; substantial equivalence is supported by materials data and design comparisons.

Technological Characteristics

Decellularized porcine collagen dermal material; fenestrated or non-fenestrated; sterile; single-use; rehydrated prior to application.

Indications for Use

Indicated for management of partial/full thickness wounds, pressure/venous/diabetic/chronic vascular ulcers, tunneled/undermined wounds, surgical wounds (donor sites, grafts, post-Moh's/laser/podiatric, dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, skin tears), and draining wounds.

Submission Summary (Full Text)

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K090954
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## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

JUL 80 2009

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of ATLAS Wound Matrix.

| Submitted By: | Wright Medical Technology, Inc. |
|-------------------------------------|-------------------------------------------------------------------|
| Date: | March 30, 2009 |
| Contact Person: | Ryan M. Belaney |
| | Sr. Regulatory Affairs Specialist/Product Development<br>Engineer |
| Proprietary Name: | ATLAS Wound Matrix |
| Common Name: | Animal-derived, extra-cellular matrix wound care<br>product |
| Classification Name and Reference: | Unclassified |
| Device Product Code and Panel Code: | General and Plastic Surgery/KGN |

#### DEVICE INFORMATION

#### A. INTENDED USE

The ATLAS Wound Matrix devices intended use is for the management of wounds including:

- partial and full thickness wounds,
- pressure ulcers,
- venous ulcers,
- diabetic ulcers.
- chronic vascular ulcers,
- tunneled/undermined wounds.
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence),
- trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
- draining wounds.

The device is supplied sterile and is intended for one-time use.

#### B. DEVICE DESCRIPTION

The design features of the ATLAS Wound Matrix are substantially equivalent to the design features of the predicate devices. A brief description of the ATLAS Wound Matrix is provided below.

#### IMPLANT DESCRIPTION

The ATLAS Wound Matrix is a sterile, decellularized fenestrated or non-fenestrated processed porcine collagen dermal material, which is rehydrated at the time of implant, is designed to be thin enough to conform to the wound it will cover. The matrix material will be made available in a variety of sizes depending on surgical use.

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### C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, type of interface, operating principles, shelf life, and design features of the ATLAS Wound Matrix are substantially equivalent to the previously cleared predicates. Additionally, the safety and effectiveness of the ATLAS Wound Matrix is adequately supported by the substantial equivalent information and materials data provided within this Premarket Notification.

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SEP 9 2009 Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. % Mr. Ryan Belaney Biologics Development Engineer 5677 Airline Road Arlington, Tennessee 38002

Re: K090954

Trade/Device Name: ATLAS Wound Matrix Regulatory Class: Unclassified Product Code: KGN Dated: July 1, 2009 Received: July 2, 2009

Dear Mr. Belaney:

This letter corrects our substantially equivalent letter of July 30, 2009.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Ryan Belaney

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For

Peter D. Ruisen
Dep D.R.

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Ko 90954

Device Name: ATLAS Wound Matrix

Indications For Use:

The ATLAS Wound Matrix is intended for the management of wounds including:

- partial and full thickness wounds, .
- pressure ulcers, .
- . venous ulcers,
- diabetic ulcers, .
- chronic vascular ulcers, .
- . tunneled/undermined wounds,
- surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, . podiatric, wound dehiscence),
- . trauma wounds (abrasions, lacerations, second-degree burns, and skin tears),
- draining wounds. .

The ATLAS Wound Matrix is a collagen wound dressing that provides an environment that supports wound healing.

The device is supplied sterile and is intended for one-time use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krane for MXM

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090954

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