STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM

K032901 · Stryker Endoscopy · GAT · Dec 2, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K032901
• Device Name: STRYKER MINI-MENDER MENISCAL REPAIR SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: GAT · General, Plastic Surgery
• Decision Date: Dec 2, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 878.5000
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears. The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.

Device Story

The Stryker Mini-Mender Meniscal Repair System is a manual surgical instrument set used for arthroscopic meniscal tear repair. The system comprises disposable pre-curved cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture, all pre-assembled to disposable introducers (needle-suture passers). The device is used by surgeons in an arthroscopic clinical setting to pass suture through soft tissue for fixation of meniscal tears. The system is provided sterile for single-use. By facilitating the placement of sutures, the device enables the surgeon to perform meniscal repair, which is considered the gold standard for treating meniscal tears, potentially benefiting the patient by restoring meniscal integrity.

Clinical Evidence

No clinical data. The device relies on bench testing and adherence to established standards (USP Section XXV, ISO-10993, ASTM 4169, EN 552) to demonstrate safety and effectiveness.

Technological Characteristics

System includes pre-curved cannulas, stainless steel needles, and USP non-absorbable braided polyester suture. Materials are biocompatible per ISO-10993 and G95-1. Sterilization via Gamma irradiation (EN 552) to a sterility assurance level of 10^-6. Packaging conforms to ASTM 4169. Device is a manual surgical instrument; no software or electronic components.

Indications for Use

Indicated for arthroscopic suture fixation of meniscal tears in patients requiring surgical repair.

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

• Linvatec SharpShooter Meniscal Repair System

Reference Devices

• Genzyme Biosurgery/Teleflex Medical suture (K021019)

Submission Summary (Full Text)

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DEC = 2 2003

K03290/
P.1/2

## ABBREVIATED 510(k)

# SUMMARY REPORT OF SAFETY AND EFFECTIVENESS AND ADHERENCE TO THE CLASS II SPECIAL CONTROLS GUIDANCE DOCUMENT: SURGICAL SUTURES ISSUED ON JUNE 3, 2003

### Device Name

The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture, The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers),

| Classification Name: | Cannula, Surgical, General & Plastic Surgery |
|------------------------|--------------------------------------------------------------|
| Device Classification: | 21 CFR §878.4800, Class I - Exempt |
| Common and Usual Name: | Cannula (GEA) |
| Classification Name: | Passer, Wire, Orthopedic |
| Device Classification: | 21 CFR §888.4540, Class I - Exempt |
| Common and Usual Name: | Passer (HXI) |
| Classification Name: | Non-Absorbable Poly(ethylene terephthalate) Surgical Sutures |
| Device Classification: | 21 CFR §878.5000, Class II |
| Common and Usual Name: | Polyester Nonabsorbable Surgical Sutures (GAT) |
| Proprietary Name: | Stryker Mini-Mender Meniscal Repair System |

#### Predicate Devices

Linvatec SharpShooter Meniscal Repair System, currently marketed by Linvated CONMED (Largo, FL).

#### Guidance Document

Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA issued on June 3, 2003

#### Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990 and of the Special Controls as defined in section 513(a)(1)(B) of the Act for an Abbreviated 510(k).

The Stryker Mini-Mender Meniscal Repair System is intended to pass suture through soft tissue for suture fixation of meniscal tears. The use of suture to repair meniscus tears is common, considered the "Gold Standard" in meniscal repair, and has been well published in professional journals such as Operative Techniques in Orthopaedics and The American Journal of Sports Medicine (See Tab 1)

The Stryker Mini-Mender Meniscal Repair System consists of a set of disposable pre-curved Cannulas and double-armed stainless steel needles pre-attached to USP non-absorbable, braided polyester surgical suture. The needles-suture are pre-assembled to a pair of disposable Introducers (needle-suture passers),

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KU72901/P2/2

Stryker will acquire suture from a suture manufacturer that has received FDA clearance for the suture, such as Genzyme Biosurgery/Teleflex Medical (510(k) #K021019), with an intended use as specified for the Mini-Mender Meniscal Repair System. Stryker will assemble the Introducer and sterilize (reprocess) the device/suture prior to market release.

The Stryker Mini-Mender Meniscal Repair System will be provided pre-assembled, sterile for single-use applications (ASTM 4169). The device will be sterilized by Gamma irradiation (EN 552) and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO-10993 and G95-1. The Stryker Mini-Mender Meniscal Repair System is substantially equivalent in intended use, safety, and efficacy to the predicate device and conforms to USP Section XXV - Nonabsorbable Surgical Sutures and the Class II Special Controls Guidance Document: Surgical Sutures issued on June 3, 2003.

The Stryker Mini-Mender Meniscal Repair System is considered substantially equivalent to the Linvatec SharpShooter Meniscal Repair System.

Contact:

82

Date: Aug. 29, 2003

Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 [phone] x.2148

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol of three wavy lines, which are meant to represent the flow of people and services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 2 2003

Ms. Melissa Murphy Regulatory Representative Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K032901 Trade/Device Name: Stryker Mini-Mender Meniscal Repair System Regulation Number: 21 CFR 878.5000, 21 CFR 888.4540 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture, Orthopedic manual surgical instrument Regulatory Class: II, I Product Code: GAT, LXH Dated: August 20, 2003 Received: September 17, 2003

Dear Ms. Murphy:

We have reviewed your Section 510(k) promarket 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.

If your device is classified (scc above) into either class II (Special Controls) or class III (PMA), 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Melissa Murphy

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by refercnce to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours.

Miriam C. Provost

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

Enclosure

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August 20, 2003

Ko3290/

510(k) Number if known:_

## INDICATION FOR USE:

The Stryker Mini-Mender Meniscal Repair System is intended for use in arthroscopic suture fixation techniques of meniscal tears.

The Stryker Mini-Mender Meniscal Repair System is intended for single-use only.

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Division of General, Restorative and Neurological Devices

510(k) Number K032901

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _