Arthrex Self Punching SwiveLock Suture Anchors

K222263 · Arthrex, Inc. · MAI · Aug 26, 2022 · Orthopedic

Device Facts

• Record ID: K222263
• Device Name: Arthrex Self Punching SwiveLock Suture Anchors
• Applicant: Arthrex, Inc.
• Product Code: MAI · Orthopedic
• Decision Date: Aug 26, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3030
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.

Device Story

Arthrex Self Punching SwiveLock Suture Anchors are orthopedic implants for soft tissue-to-bone fixation in shoulder rotator cuff repair. The device consists of a fully threaded anchor body (PLLA/βTCP or PEEK) and a PEEK eyelet, preassembled on a disposable inserter. Used by surgeons in clinical settings, the anchor is inserted into bone to secure sutures. The self-punching design facilitates implantation. The device functions as a mechanical fixation anchor; it does not involve electronic processing, software, or AI. Clinical benefit is derived from stable soft tissue reattachment to bone, promoting healing.

Clinical Evidence

Bench testing only. Performance data included pull-out and insertion testing comparing the subject device to the predicate. All samples met acceptance criteria, demonstrating substantial equivalence.

Technological Characteristics

Materials: PEEK and PLLA/βTCP. Design: Fully threaded suture anchor with self-punching PEEK eyelet. Delivery: Preassembled on a disposable inserter. Sterilization: Not specified. Connectivity: None (mechanical device).

Indications for Use

Indicated for suture (soft tissue) fixation to bone in the shoulder for rotator cuff repair in skeletally mature pediatric and adult patients.

Regulatory Classification

Identification

Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• Arthrex SwiveLock Suture Anchor (K191226)

Reference Devices

• Arthrex SwiveLock Anchor (K203495)
• Arthrex SwiveLock Suture Anchor (K193503)

Submission Summary (Full Text)

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August 26, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Arthrex Inc. Tiffany Mentzel Principal Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

### Re: K222263

Trade/Device Name: Arthrex Self Punching SwiveLock® Suture Anchors Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: July 27, 2022 Received: July 28, 2022

Dear Tiffany Mentzel:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Laura C. Rose, PhD Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K22263

#### Device Name

Arthrex Self Punching SwiveLock® Suture Anchors

Indications for Use (Describe)

The Arthrex Self Punching SwiveLock® Suture Anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in skeletally mature pediatric and adult patients. Specifically, rotator cuff repair.

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

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| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <rect height="10.6667" stroke="black" stroke-width="1.33333" width="13.3333" x="1.33325" y="2.66663"></rect> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/1 description: The image shows the Arthrex logo. The logo consists of the word "Arthrex" in a bold, sans-serif font, followed by a stylized image of a surgical instrument. The surgical instrument appears to be a type of clamp or forceps, with a handle and two circular ends. The logo is simple and modern, and it is likely used to represent a medical device company.

# 510(k) Summary

| Date Prepared | July 27, 2022 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Arthrex Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 |
| Contact Person | Name: Tiffany Mentzel<br>Title: Principal Regulatory Affairs Specialist<br>Phone: [phone] x75833<br>Email: [e-mail] |
| Trade Name | Arthrex Self Punching SwiveLock® Suture Anchors |
| Common Name | Suture Anchor |
| Product Code | MAI, MBI |
| Classification Name | 21 CFR 888.3030: Single/multiple component<br>metallic bone fixation appliances and accessories<br>21CFR 888.3040: Smooth or threaded metallic<br>bone fixation fastener |
| Regulatory Class | II |
| Primary Predicate Device | K191226: Arthrex SwiveLock Suture Anchor |
| Reference Devices | K203495: Arthrex SwiveLock Anchor<br>K193503: Arthrex SwiveLock Suture Anchor |
| Purpose of Submission | This Special 510(k) premarket notification is<br>submitted to obtain clearance for the Arthrex Self<br>Punching SwiveLock Suture Anchors as a line<br>extension to the Arthrex SwiveLock Suture Anchors<br>cleared in K191226. |
| Device Description | The proposed Arthrex Self Punching SwiveLock®<br>Suture Anchors are fully threaded suture anchors<br>comprised of a PEEK eyelet and a hollow anchor<br>body preassembled on a disposable inserter. The<br>anchor body is manufactured from either<br>PLLA/βTCP or PEEK. The Arthrex Self Punching<br>SwiveLock® Suture Anchor is intended to be used<br>for suture (soft tissue) fixation to the bone in the<br>shoulder. |
| Indications for Use | The Arthrex Self Punching SwiveLock® Suture<br>Anchors are intended to be used for suture (soft<br>tissue) fixation to bone in the shoulder in skeletally |
| | mature pediatric and adult patients. Specifically,<br>rotator cuff repair. |
| Performance Data | Pull-out and insertion testing was performed on the<br>proposed and predicate devices. The acceptance<br>criteria were met for all samples, demonstrating<br>substantial equivalence to the predicate. |
| Technological<br>Comparison | The proposed device has the same technological<br>characteristics (anchor design, material,<br>sterilization method and biocompatibility profile).<br>The proposed device modification consists of a<br>PEEK self punching eyelet. The Arthrex Self<br>Punching SwiveLock® Anchors are substantially<br>equivalent to the predicate device in which the<br>design features and intended uses are the same.<br>Any differences between the proposed device and<br>the predicate devices are considered minor and do<br>not result in new or different questions concerning<br>safety or effectiveness. |
| Conclusion | The Arthrex Self Punching SwiveLock® Anchors<br>are substantially equivalent to the predicate<br>devices in which the basic design features and<br>intended use are the same. Any differences<br>between the proposed device and the predicate<br>devices are considered minor and do not result in<br>new or different questions concerning safety or<br>effectiveness. Based on the indications for use,<br>technological characteristics, and the summary of<br>data submitted, Arthrex has determined that the<br>proposed device is substantially equivalent to the<br>currently marketed predicate device. |

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Image /page/4/Picture/1 description: The image shows the logo for Arthrex, a medical device company. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word "Arthrex" is an image of a surgical instrument, possibly scissors or forceps. The logo is simple and modern, and it is likely used on the company's products and marketing materials.