TORNIER SURGICAL MESH

K093799 · Tornier, Inc. · FTL · Apr 22, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K093799
• Device Name: TORNIER SURGICAL MESH
• Applicant: Tornier, Inc.
• Product Code: FTL · General, Plastic Surgery
• Decision Date: Apr 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Tornier® Surgical Mesh is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Tornier® Surgical Mesh is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons. Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Device Story

Tornier Surgical Mesh is a bi-layer, synthetic, absorbable, woven fabric composed of poly(4-hydroxybutyrate) fibers. Designed for surgical reinforcement of soft tissues where weakness exists or for hernia/fascial defect repair. Used in tendon repair surgeries as a reinforcing material in conjunction with sutures and bone anchors. Supplied sterile for single-patient use; cut to desired shape/size by surgeon. Does not provide full mechanical strength for tendon repair; primary mechanical support remains provided by sutures and anchors. Benefits include temporary wound support and reinforcement of weakened tissues.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing conducted per ISO 10993 and performance testing consistent with FDA guidance for surgical mesh.

Technological Characteristics

Bi-layer, synthetic, absorbable, woven fabric. Material: poly(4-hydroxybutyrate) fibers. Form factor: cut-to-size mesh. Sterilization: sterile. No software or electronic components.

Indications for Use

Indicated for patients requiring temporary soft tissue reinforcement for hernia repair, fascial defects, or as an adjunct to sutures/anchors in tendon repair (rotator cuff, patellar, Achilles, biceps, quadriceps). Not for use as a structural replacement for tendons.

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

• TephaFLEX™ Surgical Mesh (K070894)
• Artelon® SportMesh™ Tissue Reinforcement Surgical Mesh (K071887)
• LTM-RC Surgical Mesh (K071986)

Submission Summary (Full Text)

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K093799

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#### 510(k) SUMMARY (Per 21 CFR 807.92)

## General Company Information

4.1

# APR 2 2 2010

- Tornier, Inc. Name: Contact: Howard Schrayer Regulatory Affairs Consultant
- 3601 W. 76th Street Address: Suite 200 Edina, MN 55435
- Telephone: (978) 232 - 9997 (978) 232 - 9998 Fax:
- Date Prepared December 9, 2009

#### General Device Information

- Product Name: Tornier® Surgical Mesh
- Classification: "Absorbable Surgical Mesh" Product code: FTL - Class II

# Predicate Device

| Tepha, Inc. | TephaFLEX™ Surgical Mesh<br>[510(k) Number K070894] |
|----------------|--------------------------------------------------------------------------------------|
| Artimplant AB | Artelon® SportMesh™ Tissue Reinforcement<br>Surgical Mesh<br>[510(k) Number K071887] |
| LifeCell Corp. | LTM-RC Surgical Mesh<br>[510(k) K071986] |

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#### Description

Tornier® Surgical Mesh is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile, for single-patient use for the reinforcement of soft tissue where weakness exists.

#### Intended Use (Indications)

Tornier® Surgical Mesh is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Tornier® Surgical Mesh is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.

Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

## Substantial Equivalence

This submission supports the position that the Tornier™ Surgical Mesh System is substantially equivalent to previously cleared devices, including those listed above. Substantial equivalence has been demonstrated by conduct of applicable biocompatibility testing as outlined in ISO10993. In addition, Tornier has conducted testing consistent with the requirements of the Guidance Document entitled: "Guidance for the Preparation of a Premarket Notification for a Surqical Mesh" (March 2. 1999) A number of predicate devices list the same range of clinical uses.

#### Conclusions

Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier™ Surgical Mesh System. The materials from which the Tornier device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.

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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 features 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 bird symbol. The text is in all caps and appears to be in a sans-serif font.

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

# APR 22 2010

Tornier, Inc. % Mr. Howard L. Schrayer 100 Cummings Center, Suite 444C Beverly, Massachusetts 01915

Re: K093799

Trade/Device Name: Tornier® Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: April 14, 2010 Received: April 16, 2010

Dear Mr. Schrayer:

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 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

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Page 2 - Mr. Howard L. Schrayer

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/ucm11.5809.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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

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

Enclosure

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K093799

#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Tornier® Surgical Mesh

Indications For Use:

Tornier® Surgical Mesh is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.

Tornier® Surgical Mesh is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.

Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

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)

for DKK

Dististince of broical, Orthopedic, and Restor. Tive Devices

510(k) Number: K093799