STRYKER BIOZIP SUTURE ANCHOR

K023192 · Stryker Endoscopy · HWC · Mar 20, 2003 · Orthopedic

Device Facts

• Record ID: K023192
• Device Name: STRYKER BIOZIP SUTURE ANCHOR
• Applicant: Stryker Endoscopy
• Product Code: HWC · Orthopedic
• Decision Date: Mar 20, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Repair Capsular Shift/Capsulolabral Reconstruction Biceps Tenodesis Deltoid Repair. Knee: Extra Capsular Repairs Medial Collateral Ligament Lateral Collateral Ligament Posterior Oblique Ligament Illiotibial Band Tenodesis Patellar Tendon Repair. Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment. Foot and Ankle: Medial Instability Repair/Reconstruction Lateral Instability Repair/Reconstruction Achilles Tendon Repair/Reconstruction Midfoot Reconstruction Hallux Valgus Reconstruction. Pelvis: Bladder Neck Suspension Procedures. The Stryker BioZip Suture Anchor is intended for single-use only.

Device Story

Bioabsorbable screw-in suture anchor; PLLA material; pre-threaded with two non-absorbable USP braided polyester sutures; preloaded on disposable inserter. Used in orthopedic reconstructive surgery to secure soft tissue to bone. Surgeon inserts device by rotating inserter to screw anchor into bone; suture ends then used to secure tissue. Provides mechanical fixation during healing; anchor eventually absorbs. Used in OR setting by orthopedic surgeons.

Clinical Evidence

Bench testing only. Biocompatibility per ISO-10993 and G95-1. Sterility validated to SAL 10^-6 per EN550.

Technological Characteristics

Material: Poly L-lactic acid (PLLA). Suture: Non-absorbable USP braided polyester. Design: Screw-in anchor with eyelets and hex-shaped cannulated core. Sterilization: Ethylene Oxide (EN550). Packaging: ASTM 4169. Single-use.

Indications for Use

Indicated for patients undergoing reconstructive surgery requiring soft tissue-to-bone fixation in the shoulder, knee, elbow, wrist, hand, foot, ankle, or pelvis. Contraindications not specified.

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

• Arthrex 5.0 mm Bio-Corkscrew Suture Anchor (K990987)

Submission Summary (Full Text)

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K027192

page 171

MAR 2 0 2003

# SUMMARY OF SAFETY AND EFFECTIVENESS

#### Device Name

Classification Name: Classification: Common and Usual Name: Proprietary Name:

Fastener, Fixation, Biodegradable, Soft Tissue 21 CFR §888.3040, Class II Bioabsorbable Suture Anchor Stryker BioZip Suture Anchor

#### Predicate Device

Arthrex 5.0 mm Bio-Corkscrew Suture Anchor (#K990987) currently marketed by Arthrex, Inc. (Naples, FL).

### Summary

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

The Stryker BioZip Suture Anchor is intended for use in reconstructive surgery to secure soft tissue to bone using suture. The suture anchor fixation technique is a common method in orthopedic surgery, and has been well published in professional journals such as Arthroscopy: The Journal of Arthroscopic and Related Surgery.

The Stryker BioZip Suture Anchor consists of a Poly L-lactic acid (PLLA) screw-in type suture anchor pre-threaded with two non-absorbable USP braided polyester sutures (one white and one green, needles attached) preloaded on a disposable inserter. The anchor is a bio-absorbable screw with eyelets to receive the sutures and a hex shaped cannulation down its center to accept the inserter's hex shaped tip mates with the anchors hex shaped cannulated core. By rotating the inserter the anchor is screwed into the bone. Once in place the ends of the suture are used to secure soft tissue to the bone.

The Stryker BioZip Suture Anchor will be provided sterile for single-use (ASTM 4169). The device will be sterilized by Ethylene Oxide (EN550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 10th. The device is biocompatible per ISO-10993 and G95-1. The Stryker BioZip Suture Anchor is equivalent in intended use, safety, and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

The Stryker BioZip Suture Anchor is considered substantially equivalent to the Arthrex Bio-Corkscrew Suture Anchor.

Contact:

Date: 01/15/03

Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 [phone]

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Ms. Alisa Miller Senior Quality Engineer Stryker Endoscopy 5900 Optical Court San Jose, California 95138

Re: K023192

Trade/Device Name: Stryker Biozip Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: January 15, 2003 Received: January 21, 2003

Dear Ms. Miller:

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.

If your device is classified (see 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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Alisa Miller

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 reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

s Mark N Milkers

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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January 15, 2003

510(k) Number: K023192

## INDICATION FOR USE:

The Stryker BioZip Suture Anchor is a soft tissue anchor that will be used to secure soft tissue to

bone during reconstructive surgery. The anchor is intended for use in such procedures as:

Shoulder: Rotator Cuff Repair Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Repair Capsular Shift/Capsulolabral Reconstruction Biceps Tenodesis Deltoid Repair.

Knee: Extra Capsular Repairs Medial Collateral Ligament Lateral Collateral Ligament Posterior Oblique Ligament Illiotibial Band Tenodesis Patellar Tendon Repair. '

Elbow, Wrist, Hand: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Biceps Tendon Reattachment.

Foot and Ankle: Medial Instability Repair/Reconstruction Lateral Instability Repair/Reconstruction Achilles Tendon Repair/Reconstruction Midfoot Reconstruction Hallux Valgus Reconstruction.

Pelvis: Bladder Neck Suspension Procedures.

The Stryker BioZip Suture Anchor 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)

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

| Labels | Values |
|---------------|---------|
| 510(k) Number | K023192 |

Prescription Use `Yes` OR Over-the-Counter Use `No`
(Per 21 CFR 801.109)

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