DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT

K001738 · DePuy Orthopaedics, Inc. · FTM · Dec 27, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K001738
• Device Name: DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT
• Applicant: DePuy Orthopaedics, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Dec 27, 2000
• 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 limited to the supraspinatus during rotator cuff repair surgery.

Device Story

Restore Orthobiologic Soft Tissue Implant is a resorbable scaffold derived from porcine small intestine submucosa (SIS). Device consists of 10 plys of SIS, composed primarily of collagen and water. Implanted by surgeons during general surgical procedures or rotator cuff repair; serves as a mechanical scaffold to assist soft tissue repair. Over time, device resorbs and is replaced by patient's own tissue. Provides reinforcement for soft tissues repaired via suture or suture anchors. Benefits include structural support during healing process.

Clinical Evidence

No clinical data provided; substantial equivalence based on material composition and design similarity to legally marketed predicate devices.

Technological Characteristics

Material: 10-ply porcine small intestine submucosa (SIS) composed of collagen and water. Form factor: Round implant. Function: Resorbable scaffold for soft tissue reinforcement.

Indications for Use

Indicated for patients requiring reinforcement of soft tissue where weakness exists, including reinforcement of supraspinatus 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

• Cook Biotech Inc. Surgisis Surgical Mesh (K980431)
• Cook Biotech Inc. SIS Wound Dressing (K973170)
• Cook Biotech Inc. SIS Wound Dressing II (K993948)
• Cook Biotech Inc. Surgisis Sling (K992159)
• Bio-Vascular Peri-guard (K983162)
• Bio-Vascular Peri-Strips (K992159)
• Organogenesis Graft Patch (K970561)
• Sentron SIS Hernia Repair Device (K974540)

Submission Summary (Full Text)

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# DEC 2 7 2000

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## SUMMARY OF SAFETY AND EFFECTIVEN

NAME OF SPONSOR:

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

510(k) CONTACT:

Marcia J. Arentz Senior Regulatory Associate

TRADE NAME:

DePuy Restore® Orthobiologic Soft Tissue Implant

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

#### SUBSTANTIALLY EQUIVALENT DEVICES:

- · Cook Biotech Inc. Surgisis Surgical Mesh (K980431)
- · Cook Biotech Inc. SIS Wound Dressing (K973170)
- · Cook Biotech Inc. SIS Wound Dressing II (K993948)
- + Cook Biotech Inc. Surgisis Sling (K992159)
- · Bio-Vascular Peri-guard (K983162)
- · Bio-Vascular Peri-Strips (K992159)
- · Organogenesis Graft Patch (K970561)
- · Sentron SIS Hernia Repair Device (K974540)

## 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 approved K982330 for use in general surgical procedures for reinforcement of soft tissue where weakness exists.

The Restore Orthobiologic Soft Tissue Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The device is intended to act as a resorbable scaffold that initially has sufficient strength to assist with a soft tissue repair, but then resorbs and is replaced by the patient's own tissue. The device is also intended for reinforcement of the soft tissues which are repaired by suture or suture anchors, limited to the supraspinatus, during rotator cuff repair surgery.

#### BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy Restore Orthobiologic Soft Tissue Implant is substantially equivalent to the above listed devices in that it is manufactured from the same material (SIS, porcine small intestine submucosa) as the Sentron SIS Hernia Repair Device and the Cook Biotech Inc. SIS Wound Dressing and SIS Surgical Mesh and Sling. The material is very similar to that of the Organogenesis Graft Patch (cross-linked porcine collagen). It has the same general intended use as the Organogenesis Graft Patch, the Bio-Vascular Supple Peri-guard, and the SIS Surgical Mesh and it has a similar design to all of these soft tissue patches. It has the additional specific intended use for reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery which is substantially equivalent to the pre-amendment use of surgical mesh in rotator cuff repair.

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# DEC 2 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Marcia J. Arentz Senior Regulatory Associate Depuy Orthopaedics, Inc. P.O. Box 988 Warsaw, Indiana 46581

K001738 Re:

Trade Name: Restore® Orthobiologic Soft Tissue Implant Regulatory Class: II Product Code: FTM Dated: October 20, 2000 Received: October 23, 2000

## Dear Ms. Arentz:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Marcia J. Arentz

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely yours,

Mark H. Milliken

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

Enclosure

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# 001138

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 limited to the supraspinatus during rotator cuff repair surgery.

## Concurrence of CDRH, Office of Device Evaluation

Prescription Use OR Over-The-Counter Use
(Per 21 CFR 801.109)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K001738