DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

K071016 · DePuy Orthopaedics, Inc. · FTM · Sep 4, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K071016
• Device Name: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Sep 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patella, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Device Story

Resorbable surgical mesh scaffold; manufactured from porcine small intestinal submucosa (SIS) consisting of collagen and water. Supplied as sterile sheets or strands. Used by surgeons during tendon repair or periosteum reconstruction to reinforce weakened soft tissue. Device acts as a scaffold for host tissue ingrowth; replaced by patient's own tissue over time. Does not provide primary biomechanical strength; requires sutures or bone anchors for structural support. Used in clinical/surgical settings.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, viral inactivation testing, and mechanical testing to demonstrate suitability for soft tissue reinforcement.

Technological Characteristics

Material: Porcine small intestinal submucosa (SIS) (collagen/water). Form factor: Sterile sheets or strands. Resorbable scaffold. No electronic or software components.

Indications for Use

Indicated for reinforcement of soft tissue where weakness exists, specifically for tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps, and others) and general tissue reconstruction of the periosteum. Not intended to replace body structure or provide full mechanical strength for tendon repair; requires concurrent use of sutures or bone anchors.

Regulatory Classification

Identification

Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.

Predicate Devices

• DePuy Restore Orthobiologic Soft Tissue Implant (K031969)
• CryoLife ProPatch Soft Tissue Repair Matrix (K061892)
• W.L. Gore Absorbable Mesh (K033671)

Submission Summary (Full Text)

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510(k) Premarket Notification DePuv Restore Orthobiologic Soft Tissue Implant

K07/016
Page ① of ②

#### 510(k) SUMMARY 7.0

NAME OF SPONSOR:

Depuy Orthopaedics, Incorporated 700 Orthopaedic Drive Warsaw, Indiana 46581

510(k) CONTACT: Kathy Harris Director of Regulatory Affairs

SEP - 4 2007

DATE: March 30, 2007

TRADE NAME: DePuy Restore Orthobiologic Soft Tissue Implant COMMOM NAME: Surgical Mesh 21 CFR §878.3300, Class II CLASSIFICATION: PRODUCT CODE: FTM

#### SUBSTANTIALLY EQUIVALENT DEVICES:

- DePuy Restore Orthobiologic Soft Tissue Implant (K031969) .
- CryoLife ProPatch Soft Tissue Repair Matrix (K061892) .
- W.L. Gore Absorbable Mesh (K033671) .

### DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Restore Orthobiologic Soft Tissue Implant is manufactured from porcine small intestinal submucosa (SIS), comprised predominantly of water and collagen, and will be supplied in a sheet or strand configuration in sterile form in a sealed double pouch system.

The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patella, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices (K031969, K061892, K033671) in that it is manufactured from the same material (SIS) as K031969, and has the same intended use and similar indications as K031969, K061892, and K033671, raising no new types of safety and effectiveness questions.

#### DISCUSSION OF TESTS AND TEST RESULTS:

The DePuy Restore Orthobiologic Soft Tissue Implant met the requirements of extensive biocompatibility testing, viral inactivation testing, and mechanical testing, demonstrating suitability for use.

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510(k) Premarket Notification DePuy Restore Orthobiologic Soft Tissue Implant

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## CONCLUSIONS DRAWN FROM TESTS:

Outcomes from the evaluation of the DePuy Restore Orthobiologic Soft Tissue Implant provide evidence of its suitability for use in soft tissue repair and substantial equivalency to predicate devices in terms of intended use and technological characteristics.

# 0000019

は

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DePuy Orthopaedics, Inc % Ms. Kathy Harris Director Regulatory Affairs 700 Orthopaedic Drive PO Box 988 Warsaw, IN 46581-0988

SEP - 4 2007

Re: K071016

Trade/Device Name: DePuy Restore Orthobiologic Soft Tissue Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM Dated: August 10, 2007 Received: August 13, 2007

Dear Ms. Harris:

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, listing 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 such 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); good manufacturing practice requirements as set

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Page 2 - Mr. Stephen Meade

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrb/industry/support/index.html.

Sincerely yours,

Neil R. Oslin

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

Enclosure

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### Indications for Use Form

510(k) Number (if known):

Device Name: DePuy Restore Orthobiologic Soft Tissue Implant

#### Indications For Use:

The DePuy Restore Orthobiologic Soft Tissue Implant is intended to reinforce soft tissue where weakness exists, specifically for the reinforcement of soft tissue repaired by sutures or suture anchors during tendon repair surgery, including reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps, and other tendons. The device is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair of the rotator cuff, patellar, Achilles, biceps, quadriceps or other tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. The DePuy Restore Orthobiologic Soft Tissue Implant is also intended for use during general tissue reconstruction of the periosteum. The device reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neilson Odlum

Page 1 of 1

(Division Sign-Off) Division of General. Restorative, and Neurological Devices

**510(k) Number** K071016

000029