PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF

K112786 · Synovis Orthopedic and Woundcare, Inc. · FTM · Oct 25, 2011 · General, Plastic Surgery

Device Facts

• Record ID: K112786
• Device Name: PROSERIES BIOIMPLANTS-PROANKLE/PROCUFF
• Applicant: Synovis Orthopedic and Woundcare, Inc.
• Product Code: FTM · General, Plastic Surgery
• Decision Date: Oct 25, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PROseries™ Bioimplants are 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. PROseries Bioimplants are 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

PROseries Bioimplants consist of decellularized, crosslinked equine pericardial collagen matrix reinforced with woven polymer; designed for permanent soft tissue reinforcement. Device implanted by surgeons during reconstructive or tendon repair procedures. Acts as scaffold to reinforce tissues repaired via sutures or bone anchors; does not provide primary mechanical strength for tendon repairs. Requires rinsing prior to implantation. Benefits include structural reinforcement of repaired soft tissue sites.

Clinical Evidence

Biocompatibility testing, biomechanical bench testing, and in vivo performance testing conducted to evaluate biological safety and biomechanical performance.

Technological Characteristics

Collagen matrix derived from equine pericardial tissue; decellularized and crosslinked; reinforced with woven polymer. Liquid chemical sterilization. Complies with USP sterility and LAL endotoxin limits.

Indications for Use

Indicated for patients requiring soft tissue reinforcement during reconstructive procedures (abdominal/thoracic wall, hernias, muscle flaps) or tendon repair surgery (rotator cuff, patellar, Achilles, biceps, quadriceps). Not indicated 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® PR Bioimplant (K090288)

Submission Summary (Full Text)

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

### 510(K) SUMMARY

K112786
OCT 25 2011

#### Submitter Information 1

2

| 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 |
| F. | Date: | October 17, 2011 |
| Device Identification | | |
| A. | Device Trade Name: | PROseriesTM Bioimplants-PROcuffTM/PROankleTM |
| B. | Models: | PROcuffTM, PROankleTM, PROxxx (TBD) |
| C. | Common Name: | Surgical Mesh |
| D. | Classification Name(s): | Mesh, Surgical |
| E. | Classification Regulation: | 878.3300 |
| F. | Device Class: | Class II |
| G. | Device Code(s): | FTM, FTL |
| H. | Advisory Panel: | General and Plastic Surgery |

#### 3 Identification of Predicate Device

The PROseries™ Bioimplants – PROcuff™/PROankle™ are substantially equivalent to the OrthADAPT® PR Bioimplant, Pegasus Biologics, Inc., K090288.

#### 4 Device Description

PROseries Bioimplants are comprised of collagen matrix reinforced by a woven polymer to provide permanent durability. The collagen matrix, derived from equine pericardial tissue, 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.

Page 1 of 2

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

#### 5 Statement of Intended Use

PROseries™ Bioimplants are 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.

PROseries Bioimplants are 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 PROseries Bioimplants.

#### 7 Comparison with Predicate Devices

The PROseries Bioimplants are identical to the predicate device in terms of design, technology, intended use, materials, performance and processing methods.

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

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

Synovis Orthopedic and Woundcare, Inc. % Ms. Amy Boucly Manager, Regulatory Affairs 6 Jenner Street, Suite 150 Irvine, California 92618

OCT 2 5 2011

Re: K112786

Trade/Device Name: PROseries Bioimplants – PROcuff"/PROankle"* Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTM, FTL Dated: September 23, 2011 Received: September 27, 2011

Dear Ms. Boucly:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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

Page 2 - Ms. Amy Boucly

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.

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/ReportalProblem/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,

For No. 10.11.20

Mark N. Melkerson

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

Enclosure

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

# Indications for Use

## 510(k) Number (if known): K112786

Device Name:

PROseries Bioimplants - PROcuff /PROankle

Indications For Use:

PROseries™ Bioimplants are 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, abuominal and other reconstructive procedures.

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

PROseries Bioimplants are 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 (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)

Dail Kucie for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112786

Page 1 of 1

.