Stryker All-PEEK Knotless Anchor System

K181083 · Stryker · MBI · Jul 23, 2018 · Orthopedic

Device Facts

• Record ID: K181083
• Device Name: Stryker All-PEEK Knotless Anchor System
• Applicant: Stryker
• Product Code: MBI · Orthopedic
• Decision Date: Jul 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

System consists of PEEK cannulated screws and separate eyelets; used for soft-tissue to bone fixation. Surgeon inserts eyelet and screw into bone directly or via pilot hole; screws may be used without eyelet for suture fixation. Provided sterile with disposable screwdrivers/inserters or separately for manual loading. Suture threader included. Used in orthopedic surgical procedures; provides mechanical fixation of soft tissue to bone to facilitate healing. Benefits patient by securing tissue during repair.

Clinical Evidence

Bench testing only. Evaluated ultimate tensile strength (UTS) and insertion performance. Results demonstrated equivalent or higher pull-out strength compared to predicate. Material-mediated pyrogenicity and bacterial endotoxin testing passed.

Technological Characteristics

Materials: PEEK. Design: Cannulated screws with separate eyelets. Energy: Mechanical. Connectivity: None. Sterilization: Sterile. Software: None.

Indications for Use

Indicated for soft-tissue to bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip procedures including rotator cuff, Bankart, SLAP, biceps, ligament, and tendon repairs/reconstructions.

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 SwiveLock Anchors (K151342)

Reference Devices

• Stryker ReelX STT Suture Anchor System (K120824)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue rectangle with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 ([e-mail]) or phone [phone] 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)

| <div> <span style="font-size:10pt">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
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| <div> <span style="font-size:10pt">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
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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 Specialist<br>Phone: [phone]<br>Fax: [phone] |
|-----------------|-------------------------------------------------------------------------------------------------|
| 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 (21<br>CFR 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

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

# 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.