The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

It is indicated for use in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair

Hand/Wrist: Scapholunate Ligament Reconstruction. Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair

Device Description

The Stryker All-PEEK Knotless Anchor System (herein referred to as the proposed device(s)) consists of poly-ether-ether-ketone (PEEK) cannulated screws with a separate eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without evelets.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Stryker All-PEEK Knotless Anchor System. Unlike AI/ML medical devices, this is a traditional medical device (an implantable anchor system), and as such, the information requested regarding AI/ML device testing (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth establishment) is not applicable.

The acceptance criteria and the study proving the device meets these criteria are focused on the mechanical and biocompatibility performance of the physical device.

Here's an analysis based on the provided text:

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state numerical acceptance criteria in a table format, but it describes the types of tests conducted and their qualitative outcomes. The primary performance characteristic evaluated for this type of device is its mechanical strength, specifically pull-out strength, and its biocompatibility.

Acceptance Criteria Category	Specific Test/Characteristic	Reported Device Performance
Mechanical Performance	Ultimate Tensile Strength (UTS) - Indirectly assessed via pull-out strength	"The proposed devices demonstrated equivalent or higher pull-out strength to the predicate devices."
Insertion Performance	Insertion Testing	Conducted, no specific quantitative result provided, but implies successful insertion.
Biocompatibility	Material-mediated pyrogenicity	"passing results below the required limits."
	Bacterial endotoxins	"passing results below the required limits."

Study Details (Applicable to Traditional Medical Devices)

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document mentions "The proposed devices" and "predicate devices," implying multiple units were tested. The specific number of units tested for ultimate tensile strength, insertion, pyrogenicity, and endotoxins is not provided.
- Data Provenance: The studies were benchtop non-clinical tests conducted by Stryker. There is no patient data involved, so concepts like "country of origin" or "retrospective/prospective" are not applicable.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This is not applicable for a traditional mechanical device. "Ground truth" in this context would be the objective measurement of physical properties (e.g., force in Newtons for pull-out strength) using validated test methods and equipment, not subjective expert assessment. The engineers and technicians performing the tests would be qualified in mechanical testing and material science.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for human-reviewed data (e.g., medical images). Here, the evaluation is based on objective, quantifiable physical measurements, not interpretation.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, not applicable. MRMC studies are used for evaluating diagnostic or prognostic devices where human interpretation of data (e.g., images) is involved. This device is a surgical implant.
If a Standalone Performance Study (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This refers to AI/ML algorithm performance. The "device" here is a physical implant. Its "standalone performance" is its mechanical integrity and biocompatibility, which was indeed evaluated in the benchtop studies.
The Type of Ground Truth Used:
- The "ground truth" for this device's performance is objective physical and chemical measurements obtained through standardized engineering and biocompatibility testing. For instance, the "ground truth" for pull-out strength would be the measured force required to pull out the anchor from a bone substitute, compared against a validated standard or predicate device performance. For biocompatibility, it's the measured levels of pyrogens and endotoxins against established thresholds.
The Sample Size for the Training Set:
- Not applicable. There is no "training set" as this is not an AI/ML device.
How the Ground Truth for the Training Set was Established:
- Not applicable.

Conclusion

The acceptance criteria for the Stryker All-PEEK Knotless Anchor System, as presented in the 510(k) summary, revolve around demonstrating substantial equivalence to an existing predicate device based on its intended use, indications for use, material composition, general design, operational principle, and crucially, equivalent or superior mechanical and biocompatibility performance through non-clinical benchtop testing. The document states that the proposed device demonstrated "equivalent or higher pull-out strength to the predicate devices" and passed biocompatibility tests, indicating it met the necessary performance criteria for 510(k) clearance.

Summary

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July 23, 2018

Stryker Katie Farraro Senior Regulatory Affairs Specialist 5900 Optical Court San Jose, California 95138

Re: K181083

Trade/Device Name: Stryker All-PEEK Knotless Anchor System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 23, 2018 Received: April 24, 2018

Dear Ms. Farraro:

We have reviewed vour 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. Isting of devices, good manufacturing practice, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract hability 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

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

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181083

Device Name Stryker All-PEEK Knotless Anchor System

Indications for Use (Describe)

The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

It is indicated for use in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair and Bunionectomy

K.nee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Secondary Fixation for ACL/PCL Reconstruction or Repair

Hand/Wrist: Scapholunate Ligament Reconstruction. Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary

I. SUBMITTER

Stryker Endoscopy 5900 Optical Ct San Jose, CA 95138

Contact Person:	Katie Farraro, Senior Regulatory Affairs SpecialistPhone: 408-754-2285Fax: 408-754-2507
Date Prepared:	June 22, 2018

II. DEVICE

Name of Device:	Stryker All-PEEK Knotless Anchor System
Common or Usual Name:	Suture, Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener (21CFR 888.3040)
Regulatory Class:	II
Product Code:	MBI

III. PREDICATE AND REFERENCE DEVICE

Predicate Device: Arthrex SwiveLock Anchors Company Name: Arthrex 510(k) Number: K151342

Reference Device: Stryker ReelX STT Suture Anchor System Company Name: Stryker 510(k) Number: K120824

There has been one Class II recall for the predicate device due to eyelet breakage during insertion of six product configurations. The recall was initiated by the firm in March 2017.

There have been no design-related recalls for the reference device.

IV. DEVICE DESCRIPTION

The Stryker All-PEEK Knotless Anchor System (herein referred to as the proposed device(s)) consists of poly-ether-ether-ketone (PEEK) cannulated screws with a separate

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eyelet. The anchor system is designed for insertion of the eyelet and screw into bone either directly or by using instrumentation for creation of a pilot hole. Alternatively, screws may be used without the eyelet for suture fixation in a pre-drilled pilot hole by means of a cannulated screwdriver. Screws and eyelets may be provided either preloaded on respective disposable screwdrivers and inserters, or separately for manual loading. A suture threader is included with the eyelet inserter to facilitate loading of suture through the eyelet. Anchor systems are provided sterile and are packaged in single-use sterile barrier systems (SBS) that include one or more screws with or without evelets.

V. INTENDED USE

The Stryker All-PEEK Knotless Anchor System is intended to be used for soft-tissue to bone fixation in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

It is indicated for use in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed All-PEEK Knotless Anchor System is identical to the predicate device in terms of intended use, indications for use, raw material intended for implantation, general anchor system design features, and operational principle. It is equivalent in terms of

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other technological characteristics and performance attributes. The minor differences between the proposed and predicate device do not raise new questions of safety and effectiveness, and these devices are substantially equivalent based on the criteria described in 21 CFR §807.100.

VII. PERFORMANCE DATA

Non-clinical benchtop testing was performed to evaluate the performance characteristics of the Stryker All-PEEK Knotless Anchor System, including ultimate tensile strength (UTS) and insertion testing. The proposed devices demonstrated equivalent or higher pull-out strength to the predicate devices, and no new issues of safety and effectiveness were identified.

Testing was also performed on the final finished devices for material-mediated pyrogenicity and bacterial endotoxins, with passing results below the required limits.

VIII. CONCLUSIONS

The information presented within this traditional premarket submission demonstrates that the Stryker All-PEEK Knotless Anchor System is substantially equivalent to the predicate device and will perform as safely and effectively within the intended use.

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.