FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,

K092508 · Smith & Nephew, Inc. · GAT · Jan 28, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092508
• Device Name: FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT,
• Applicant: Smith & Nephew, Inc.
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Jan 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

Device Story

All-inside meniscal repair device; consists of two non-absorbable polymer implants pre-tied with #2-0 non-absorbable suture; pre-loaded into needle delivery system. Used by surgeons in endoscopic or percutaneous soft tissue procedures. Device facilitates tissue fixation; implants deployed via delivery system to secure tissue. Provides mechanical stabilization for soft tissue repairs. Sterile, single-use device.

Clinical Evidence

Bench testing only. Performance data includes cyclic load and ultimate tensile strength testing demonstrating equivalence to predicate devices.

Technological Characteristics

All-inside meniscal repair system; two non-absorbable polymer implants; #2-0 non-absorbable suture; needle delivery system; sterile; single-use.

Indications for Use

Indicated for patients requiring percutaneous or endoscopic soft tissue procedures, including shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.

Regulatory Classification

Identification

Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.

Special Controls

*Classification.* Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.

Predicate Devices

• Smith & Nephew FAST-FIX Meniscal Repair System (K002261)
• Ethicon PDS Suture (N18331)

Submission Summary (Full Text)

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# SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based.

### FAST-FIX 360 Meniscal Repair System

Date Prepared: 24 NOV 2009

A. Submitter's Name:

JAN 9 8 2010

Smith & Nephew, Inc., Endoscopy Division

150 Minuteman Road

Andover, MA 01810

#### B. Company Contact

Julie Acker, RAC

Senior Regulatory Affairs Specialist

Phone: [phone]

FAX: [phone]

- C. Device Name

| Trade Name: | FAST-FIX 360 Meniscal Repair System |
|----------------------|------------------------------------------------------------------------|
| Common Name: | Suture Retention Device |
| Classification Name: | Suture Retention Device/Synthetic Nonabsorbable<br>Polyethylene Suture |
| Product Code: | GAT |
| Regulation Number: | 21 CFR §878.5000 |
| Device Class | II |
| Panel | General & Plastic Surgery |

D. Predicate Devices

The Smith & Nephew FAST-FIX 360 Meniscal Repair Systems is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: Smith & Nephew FAST-FIX Meniscal Repair System (K002261) and Ethicon PDS Suture (N18331)

#### E. Description of Device

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is an all-inside meniscal repair device. Each device includes two non-absorbable polymer implants, pre-tied with #2-0 non-absorbable suture and pre-loaded into a needle delivery system. The FAST-FIX 360 Meniscal Repair System is provided sterile for single use only.

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K092508
pg 2082

### F. Intended Use

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

## G. Comparison of Technological Characteristics

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is substantially equivalent in design, intended use and fundamental scientific technology to the predicate devices defined in this submission. The proposed devices have been demonstrated to be substantially equivalent and raise no new issues of safety and efficacy.

#### H. Summary Performance Data

Cyclic load and ultimate tensile strength performance testing demonstrate that the fixation properties of the Smith & Nephew FAST-FIX 360 Meniscal Repair System are substantially equivalent to legally marketed predicate devices.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a bird-like figure, possibly representing an eagle or other national symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Julie Acker, RAC Senior Regulatory Affairs Specialist 150 Minuteman Road Andover, Massachusetts 01810

JAN 2 8 2010

Re: K092508

Trade/Device Name: FAST-FIX 360 Meniscal Repair System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT Dated: November 24, 2009 Received: November 27, 2009

Dear Ms. Acker:

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 - Ms. Julie Acker, RAC

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/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 yours,
Mark McMillan

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

Enclosure

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K092508

### Indications for Use

510(k) Number (if known):

Device Name: FAST-F1X 360 Meniscal Repair System

Indications for Use:

The Smith & Nephew FAST-FIX 360 Meniscal Repair System is intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair and gastrostomy.

Prescription Use (Per 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)

Daniel Krone for MXM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092508