STRYKER WEDGE SUTURE ANCHOR SYSTEM

K041310 · Stryker Endoscopy · MBI · Jun 14, 2004 · Orthopedic

Device Facts

• Record ID: K041310
• Device Name: STRYKER WEDGE SUTURE ANCHOR SYSTEM
• Applicant: Stryker Endoscopy
• Product Code: MBI · Orthopedic
• Decision Date: Jun 14, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of the Stryker Wedge Suture Anchor System is for securing soft tissue to bone in such procedures as rotator cuff repair, Bankart lesion repair, and SLAP lesion repair in the shoulder, as well as Achilles tendon repair in the foot/ankle, medial collateral ligament repair in the elbow, and bladder neck suspension in the pelvis. The suture anchor engages in bone so as to provide a stable, bony attachment site for the soft tissue. The device is intended to be used primarily in arthroscopic procedures but may be used in open procedures as well, and is intended for single-use only.

Device Story

The Stryker Wedge Suture Anchor System is a mechanical fixation device used to secure soft tissue to bone. It consists of a titanium alloy (Ti 6Al 4V ELI) screw-in anchor pre-threaded with nonabsorbable braided polyethylene surgical suture and pre-assembled on a disposable inserter. The device is used by surgeons in arthroscopic or open procedures to provide a stable bony attachment site for soft tissue. By anchoring the suture into the bone, the device facilitates tissue repair, potentially improving patient outcomes in orthopedic and reconstructive surgeries. The system is provided sterile for single-use.

Clinical Evidence

Bench testing only. The device was validated for sterility (ANSI/AAMI/ISO 11135) and biocompatibility (ISO-10993-1 and G95-1). Performance was shown to be substantially equivalent to the predicate device.

Technological Characteristics

Material: Titanium alloy (Ti 6Al 4V ELI). Design: Screw-in anchor with nonabsorbable braided polyethylene suture. Form factor: Pre-assembled on a disposable inserter. Sterilization: Ethylene Oxide (ANSI/AAMI/ISO 11135). Biocompatibility: ISO-10993-1 compliant.

Indications for Use

Indicated for patients requiring soft tissue to bone fixation in procedures including rotator cuff, Bankart, and SLAP lesion repairs (shoulder); Achilles tendon repair (foot/ankle); medial collateral ligament repair (elbow); and bladder neck suspension (pelvis).

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Stryker Wedge Suture Anchor System (K983557)

Submission Summary (Full Text)

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K0413/0

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Endoscopy

## SUMMARY OF SAFETY AND EFFECTIVENESS

### Device Name

Classification Name:

Common and Usual Name: Proprietary Name:

JUN 1 4 2004

Fastener, Fixation, Non-degradable, Soft Tissue 21 CFR §888.3040, Class II Suture Anchor (MBI) Stryker Wedge Suture Anchor System

#### Predicate Device

Stryker Wedge Suture Anchor System (#K983557), currently marketed by Stryker Endoscopy (San Jose, CA).

#### Summary

This summary of Special 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The line extension of the Stryker Wedge Suture Anchor System is intended for use in providing a means for securing soft tissue to bone using suture. The line extension of the Stryker Wedge Suture Anchor System consists of a titanium alloy (Ti 6A1 4V ELI) screw-in type anchor pre-threaded with nonabsorbable braided polyethylene surgical suture, and pre-assembled on a disposable inserter.

The line extension of the Stryker Wedge Suture Anchor System will be provided sterile for single-use (ASTM 4169). The device line extension will be sterilized by Ethylene Oxide (ANSVAAMI/ISO 11135), including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10°. The device is biocompatible per ISO-10993-1 and G95-1. The line extension of the Stryker Wedge Suture Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

The line extension of the Stryker Wedge Suture Anchor System is considered substantially equivalent to the Stryker Wedge Suture Anchor System (#K983557).

Contact:

Date: May 6, 2004

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

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Public Health Service

JUN 1 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K041310

Trade/Device Name: Stryker Wedge Suture Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: May 6, 2004 Received: May 17, 2004

Dear Ms. Murphy:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosale) to regard the Medical Device Amendments, or to connities that have been reclassified in accordance with the provisions of the Federal Food, Drug, devices that have been receised in assee approval of a premarket approval application (PMA). and Cosmetic Fee (110) that the device, subject to the general controls provisions of the Act. The I ou may, morelore, manel of the Act include requirements for annual registration, listing of general controls provisions of ractice, 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 If your device is elassinod (over a coprols. Existing major regulations affecting your device can may be subject to sam adalarial egulations, 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 r least of advisou that I Dr. Pressuan that your device complies with other requirements of the Act mail i DA has made a acterinalistions administered by other Federal agencies. You must of any I cural statutes and regaranents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI N Fart 6077, idoling (21 OF X 1 at 1007), go CFR Part 820); and if applicable, the electronic form in the quality 2980115 (Sections 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) I ins letter will anow you to ogin mailoung of substantial equivalence of your device to a legally premaired predicated on: "The Privating sification 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 If you desire specific acritor 101 your 301) 594-4659. Also, please note the regulation entitled, Connact the Office of Comparket notification" (21CFR Part 807.97). You may obtain Misorallumig Uy relevelec to promanto notilities under the Act from the Division of Small other general informational 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

for 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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# Indications for Use

510(k) Number (if known): K041310

Device Name: Stryker Wedge Suture Anchor System

Indications For Use:

The intended use of the Stryker Wedge Suture Anchor System is for securing soft The intended use of the Offyier Woage Saturalf the repair, Bankart lesion repair, and tissue to both in such procedures as well as Achilles tendon repair in the foot/anian in SLAP lesion repair in the Shoulder, as wolf as repholunate ligament reconstruction in medial collateral ligament repair in the elbow, and bladder neck suspension
the hand/wrist, biceps tendon reattachment in the elbow, and blank the fland/whist, bleeps tendon roattach in the so as to provide a stable, bony
in the pelvis. The suture anchor engages in bone so as to provide a sead primerily in in the pelvis. The suttire anonor ongages in a list intended to be used primarily in attachinent site for the out tibeat." in open procedures as well, and is intended for single-use only.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 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)

iriam C. Provost

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

**510(k) Number** k041316