The Stryker PEEK Zip Suture Anchor is a soft tissue anchor which 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 PEEK Zip Suture Anchor is intended for single-use only.

Device Description

The Stryker PEEK Zip Suture Anchor is a single-use, soft tissue anchor which will be used to secure soft tissue to bone during reconstructive surgery. The anchor is intended for use in such procedures as: Shoulder, Knee, Elbow, Wrist, Hand, Foot and Ankle, Pelvis. The Stryker PEEK Zip Suture Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The screw-in anchor is pre-threaded with non-absorbable braided sutures and pre-assembled on a disposable inserter. The suture will be offered in both non-absorbable USP braided polyester suture (#K953531) and non-absorbable USP braided polyethylene suture (#K033654 and #K040472.). The Stryker PEEK Zip Suture Anchor will be validated to a SAL of 10° using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7:1995.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Stryker PEEK Zip Suture Anchor, a medical device. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the way typically discussed for AI/ML medical devices.

The document focuses on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for this type of device (a Class II orthopedic fastener). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device. This is primarily established by showing that the new device has the same intended use, similar technological characteristics, and does not raise new questions of safety or effectiveness.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this 510(k) submission.

Here's an analysis based on the information provided, highlighting why certain categories are not applicable:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Conformity to ISO 10993-1, Blue Book Memorandum G95-1.	The device uses PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer. It will be validated to a SAL of 10⁻⁶ using ethylene oxide, and EtO residuals will be tested according to ISO 10993-7:1995. The material differences between the Stryker PEEK Zip and Stryker BioZip (predicate) do not affect safety and efficacy. The device is considered substantially equivalent in material composition to the Arthrex PEEK Corkscrew FT (predicate).
Sterilization: Validation to a Sterility Assurance Level (SAL) of 10⁻⁶.	Validated to a SAL of 10⁻⁶ using ethylene oxide (EtO). EtO residuals tested per ISO 10993-7:1995.
Safety and Performance Standards: Conformity to EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971.	The device "will conform" to these voluntary safety and performance standards prior to market introduction. (This is a statement of intent for future compliance, not a report of completed performance against these standards within the document).
Substantial Equivalence: Demonstration that the device is as safe and effective as legally marketed predicate devices.	The document states: - "The Stryker PEEK Zip Suture Anchor is considered substantially equivalent in performance, intended use, safety, and efficacy to the Stryker BioZip Suture Anchor." - "The Stryker PEEK Zip Suture Anchor is considered substantially equivalent in material composition, intended use, safety and efficacy to the Arthrex PEEK Corkscrew FT."

2. Sample size used for the test set and the data provenance

Not Applicable. This document is a 510(k) submission focusing on substantial equivalence for a physical medical device (suture anchor), not an AI/ML device. There is no "test set" in the context of an algorithm's performance on a dataset. The "testing" involves biocompatibility, sterilization validation, and adherence to performance standards for the materials and manufacturing process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. See point 2. Ground truth is not established in this context as there's no diagnostic or predictive algorithm being evaluated against a reference standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. See point 2.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This product is a physical suture anchor, not an AI-assisted diagnostic or treatment planning system that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable. As a physical device, ground truth in the context of diagnostic or predictive accuracy is not relevant. The "ground truth" for this device relates to its material properties, biocompatibility, sterility, and mechanical performance (implicitly covered by adherence to standards and substantial equivalence claims).

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. See point 8.

Summary

{0}------------------------------------------------

MAY 16 2007

Image /page/0/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The word is all lowercase, and there is a registered trademark symbol to the right of the "r". The letters are closely spaced, giving the word a compact appearance. The overall impression is a clean and modern logo.

Endoscopy

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Date: March 19, 2007

Contact Person:

Erica A. Walters, RAC Sr. Regulatory Representative 408-754-2078(phone) 408-754-2521 (fax) erica.walters@stryker.com

Device Name:

Proprietary Name:	Stryker PEEK Zip Suture Anchor
Common and Usual Name:	PEEK Suture Anchor
Classification Name:	Screw, Fastener, Fixation, Nonabsorbable, Bone, SoftTissue (Class II, 21 CFR 888.3040, Product Code MBI,Orthopedics Review Panel)

Predicate Devices:

Stryker 5.0mm BioZip Suture Anchor: # K023192, K041305 Arthrex 5.0mm PEEK Corkscrew FT: #K061665

Device Description and Intended Use:

Shoulder:

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

Knee:

Extra Capsular Repairs
- Medial Collateral Ligament ಂ
- Lateral Collateral Ligament o
- Posterior Oblique Ligament ు
ﻻ Illiotibial Band Tenodesis
Patellar Tendon Repair. 피

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.

{1}------------------------------------------------

The Stryker PEEK Zip Suture Anchor will be manufactured from PEEK-OPTIMA® (polyetheretherketone), a biocompatible polymer manufactured by Invibio Inc. The screw-in anchor is pre-threaded with non-absorbable braided sutures and pre-assembled on a The suture will be offered in both non-absorbable USP braided polyester disposable inserter. suture (#K953531) and non-absorbable USP braided polyethylene suture (#K033654 and #K040472.). The Stryker PEEK Zip Suture Anchor will be validated to a SAL of 10° using ethylene oxide. The EtO residuals will be tested according to ISO 10993-7:1995.

Prior to introducing the Stryker PEEK Zip Suture Anchor to market, the device will conform to the following voluntary safety and performance standards: ISO 10993-1, Blue Book Memorandum G95-1, EN 550, EN 556-1, EN 11607-1, EN 11607-2, EN 980, EN 1041, and EN ISO 14971.

The material differences between the Stryker PEEK Zip Suture Anchor and Stryker BioZip Suture Anchor (K023192, K041305) do not affect the safety and efficacy of the product; therefore, the Stryker PEEK Zip Suture Anchor is considered substantially equivalent in performance, intended use, safety, and efficacy to the Stryker BioZip Suture Anchor.

The Stryker PEEK Zip Suture Anchor is considered substantially equivalent in material composition, intended use, safety and efficacy to the Arthrex PEEK Corkscrew FT (K061665).

By: Chutine Kysar

Date: 19 March 2007

Christine Krueger Design Engineer Stryker Endoscopy

{2}------------------------------------------------

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 stylized eagle-like symbol with three curved strokes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Stryker Endoscopy % Erica A. Walters, RAC Sr. Regulatory Representative 5900 Optical Court San Jose, California 95138

MAY 16 2007

Re: K070758

Trade/Device Name: Stryker PEEK Zip Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: March 19, 2007 Received: April 3, 2007

Dear Ms. Walters:

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

{3}------------------------------------------------

Page 2 - Erica A. Walters, 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. 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Karlaue Buehup
fell

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

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE

Device Name: Stryker PEEK Zip Suture Anchor

K070758 510(k) Number if known:

The Stryker PEEK Zip Suture Anchor is a soft tissue anchor which 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
프 Biceps Tenodesis
I Deltoid Repair.

Knee:

Extra Capsular Repairs .
- Medial Collateral Ligament o
- Lateral Collateral Ligament 0
- Posterior Oblique Ligament 0
. Illiotibial Band Tenodesis
I 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 I
· Lateral Instability Repair/Reconstruction
· Achilles Tendon Repair/Reconstruction
· Midfoot Reconstruction
· Hallux Valgus Reconstruction.

Pelvis:

Bladder Neck Suspension Procedures. .
The Stryker PEEK Zip Suture Anchor is intended for single-use only.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchup

Division of General. Restorative. and Neurological Devices

510(k) Number K0

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
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.(b)
Classification. Class II.