DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

K031969 · DePuy Orthopaedics, Inc. · FTM · Jul 28, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K031969
• Device Name: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Jul 28, 2003
• 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 for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues, which are repaired by suture or suture anchors, during rotator cuff repair surgery. The Restore® Implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore® Implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Device Story

Restore® Orthobiologic Soft Tissue Implant is a round, resorbable scaffold derived from 10 plys of porcine small intestine submucosa (SIS); composed of water and collagen. Used in general surgery and rotator cuff repair; intended to reinforce soft tissue repaired by sutures or anchors. Does not replace normal body structure or provide full mechanical strength; acts as a scaffold replaced by patient's own tissue. Implanted by surgeons during surgical procedures.

Clinical Evidence

Clinical data cited as evidence of safety and effectiveness for the expanded indication.

Technological Characteristics

10-ply porcine small intestine submucosa (SIS) biomaterial; resorbable scaffold; round configuration.

Indications for Use

Indicated for reinforcement of soft tissue where weakness exists and for reinforcement of soft tissues repaired by suture or suture anchors during rotator cuff repair surgery.

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

• Restore® Orthobiologic Soft Tissue Implant (K982330)
• Restore® Orthobiologic Soft Tissue Implant (K001738)

Submission Summary (Full Text)

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# JUL 2 8 2003

20319698,12

# SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF SPONSOR:

DePuy, Inc. P.O. Box 988 Warsaw, Indiana 46581-0988

510(k) CONTACT:

Kathy K. Trier, Ph.D. Senior Regulatory Associate

TRADE NAME:

COMMON NAME: CLASSIFICATION: DEVICE PRODUCT CODE: Surgical Mesh 878.3300 - Surgical Mesh 79 FTM

### SUBSTANTIALLY EQUIVALENT DEVICES:

- ◆ Restore® Orthobiologic Soft Tissue Implant (K982330)
DePuy Restore® Orthobiologic Soft Tissue Implant

- � Restore® Orthobiologic Soft Tissue Implant (K001738)
# DEVICE DESCRIPTION AND INTENDED USE:

The Restore® Orthobiologic Soft Tissue Implant is a round device, manufactured from 10 plys of Small Intestine Submucosa (SIS). SIS is a biomaterial derived from porcine small intestine. SIS is composed predominately of water and collagen. This material is identical to the material and device configuration approved in K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists and K001738 for reinforcement of the soft tissues, which are repaired by suture or suture anchors during rotator cuff repair, limited to the supraspinatus.

This submission is for the following expanded intended use:

The DePuy Restore® Orthobiologic Soft Tissue Implant is intended for use for reinforcement of the soft tissues, which are repaired by suture or suture anchors, during rotator cuff repair surgery.

The Restore® implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore® implant 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 device (K982330, K001738) in that it is manufactured from the same material (SIS, porcine small intestine submucosa), has the same device design, has the same general and specific use as the predicate device, and has the additional expanded indication for use

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03/1969 P2/2

that does not alter the therapeutic effect based upon safety and effectiveness considerations and evidenced by clinical data.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2003

Dr. Kathy K. Trier, Ph.D. Senior Regulatory Affairs Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K031969

Trade/Device Name: Restore® Orthobiologic Soft Tissue Implant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTM Dated: June 24, 2003 Received: June 26, 2003

Dear Dr. Trier:

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 mav 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 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.

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Page 2 - Dr. Kathv K. Trier, Ph.D.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Miriane C. Provost

(Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K03/969

510(k) Number (if known)

Device Name: Restore® Orthobiologic Soft Tissue Implant

Indications for Use:

The DePuy Restore® Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. In addition, the implant is intended for use in the specific application of reinforcement of the soft tissues, which are repaired by suture or suture anchors, during rotator cuff repair surgery.

The Restore® Implant is not intended to replace normal body structure or provide the full mechanical strength to repair the rotator cuff. Sutures to repair the tear and suture or bone anchors to reattach the tissue to the bone provide mechanical strength for the rotator cuff repair. The Restore® Implant reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient's own soft tissue.

Concurrence of CDRH, Office of Device Evaluation

Muriam C. Provost

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

510(k) Number K031969

Prescription Use
(Per 21 CFR 801.109) OR

Over-The-Counter Use