ORTHADAPT PR

K090288 · Pegasus Biologics, Inc. · FTL · May 5, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K090288
• Device Name: ORTHADAPT PR
• Applicant: Pegasus Biologics, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: May 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, sutureline reinforcement and other reconstructive procedures. The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons. OrthADAPT® PR 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.

Device Story

OrthADAPT® PR is a surgical mesh bioimplant consisting of a decellularized, crosslinked equine pericardial collagen matrix reinforced with a woven polymer. Designed for implantation by surgeons to reinforce soft tissue defects or tendon repairs. The device provides a scaffold for tissue reinforcement but does not replace native tissue or provide primary biomechanical strength for tendon repairs; primary strength remains dependent on sutures or bone anchors. The device requires rinsing prior to implantation. It is supplied sterile via liquid chemical sterilization. Benefits include structural reinforcement during reconstructive procedures.

Clinical Evidence

Evidence includes biocompatibility testing, biomechanical bench testing, and an animal implant study. Bench testing confirmed mechanical performance requirements were met. Animal study confirmed functionality and tissue response characteristics. No human clinical trial data provided.

Technological Characteristics

Collagen matrix derived from equine pericardial tissue, decellularized and crosslinked, reinforced with woven polymer. Sterilized via liquid chemical sterilant. Complies with USP sterility and FDA LAL endotoxin limits.

Indications for Use

Indicated for soft tissue reinforcement in patients requiring repair of abdominal/thoracic wall defects, hernias, muscle flaps, or suture-lines; also indicated for reinforcement of soft tissues during tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps). Not intended to replace body structure or provide primary mechanical strength for tendon repairs.

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

• OrthADAPT® Bioimplant (K043388, K071065)
• Avaulta Plus® BioSynthetic Support System (K063712)
• AMS Elevate® Prolapse Repair System (K080185)
• PeriPatch™ Sheet (K040835)
• SeriScaffold Surgical Mesh (K080442)
• Surgicraft Surgical Mesh System (K072370)

Submission Summary (Full Text)

{0}------------------------------------------------

K090288 page 1/2

Synovis Orthopadic and Woundcare, Inc.

OrthADAPT® PR B

## 510(K) SUMMARY

#### Submitter Information 1

| A. | Company Name: | Synovis Orthopedic and Woundcare, Inc. |
|----|--------------------|-------------------------------------------------------------|
| B. | Company Address: | 6 Jenner, Suite 150<br>Irvine, CA 92618 |
| C. | Company Phone: | [phone] |
| D. | Company Facsimile: | [phone] |
| E. | Contact Person: | Amy Boucly<br>Manager, Regulatory Affairs/Quality Assurance |
| F. | Date: | 06/25/12 |

#### Device Identification 2

| A. | Device Trade Name: | OrthADAPT® PR Bioimplant |
|----|----------------------------|-----------------------------|
| B. | Common Name: | Surgical Mesh |
| C. | Classification Name(s): | Mesh, Surgical |
| D. | Classification Regulation: | 878.3300 |
| E. | Device Class: | Class II |
| F. | Device Code(s): | FTL, FTM, OXA, OXD, OWY |
| G. | Advisory Panel: | General and Plastic Surgery |

### Identification of Predicate Devices 3

The OrthADAPT® PR Bioimplant is substantially equivalent to the following surgical mesh devices, which are cleared for commercial distribution in the United States:

- · OrthADAPT® Bioimplant, Pegasus Biologics, Inc., K043388, K071065
- · Avaulta Plus® BioSynthetic Support System, C.R. Bard, Inc., K063712
- · AMS Elevate® Prolapse Repair System, American Medical Systems (AMS) K080185
- · PeriPatch™ Sheet, PM Devices, K040835
- · SeriScaffold Surgical Mesh, Serica Technologies, Inc., K080442
- · Surgicraft Surgical Mesh System, Surgicraft, K072370

{1}------------------------------------------------

K090288 Page 2/2

Synovis Orthopedic and Woundcare, Inc.

OrthADAPT® PR Bloimplant K080288

#### 4 Device Description

OrthADAPT® PR is comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, which is derived from the same equine pericardial tissue used in the fabrication of its predicate device, the OrthADAPT® Bioimplant, has been decellularized and crosslinked and the entire device has been exposed to a liquid chemical sterilant. The product passes USP sterility testing and satisfies FDA requirements for LAL endotoxin limit for a medical device. The product must be rinsed prior to use following the procedures described in the Instructions for Use.

#### Statement of Intended Use 5

OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias, sutureline reinforcement and other reconstructive procedures.

The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

OrthADAPT® PR 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.

#### Biocompatibility and Performance Data 6

Biocompatibility testing, biomechanical bench testing, and in vivo performance testing have been conducted to evaluate the biological safety and biomechanical performance characteristics of OrthADAPT® PR, Biocompatibility test results indicate that the device biocompatibility profile is equivalent to the predicate devices. Biomechanical test results indicate that the device is equivalent to the predicate devices and satisfies mechanical performance requirements for its intended use. An animal implant study was performed to confirm the functionality and tissue response characteristics of the OrthADAPT® PR.

#### Comparison with Predicate Devices 7

The OrthADAPT® PR is comparable to the predicate devices in terms of intended use, technology and performance: It is similar to the predicate devices in that it has the same intended use of soft tissue reinforcement, is comprised of similar materials (collagen and polymeric materials) and is similar in design. The results of testing demonstrate that the performance of OrthADAPT® PR is comparable to the predicate devices.

Page 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol in blue, with its wings spread and body facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement. The text is in all caps and appears to be in a sans-serif font, also in blue.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Pegasus Biologics. Incorporated % Ms. Amy Boucly Director. Regulatory Affairs 6 Jenner Street, Suite 150 Irvine, California 92618

Re: K090288

Trade/Device Name: OrthADAPT® PR Bioimplant Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class 2 Product Code: FTL, FTM, OXA, OXD, OWX Dated: February 3, 2009 Received: February 5, 2009

AUG 2 9 2012

Dear Ms. Boucly:

This letter corrects our substantially equivalent letter of May 5, 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 (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 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 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.

{3}------------------------------------------------

### Page 2- Ms. Amy Boucly

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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

{4}------------------------------------------------

Synovis Orthopedic and Woundcare, Inc.

# INDICATIONS FOR USE

510(k) Number: K090288

Device Name: OrthADAPT® PR

Indications for Use: OrthADAPT® PR is intended to be used for implantation to reinforce soft tissue, including but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, hernias. suture-line reinforcement and other reconstructive procedures.

> The device is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.

> OrthADAPT® PR 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.

Prescription Use X (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 IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daiel Kune fur MM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090288