The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip 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, Midfoot Reconstruction, Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.

. Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).

. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
. Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.

. Hip: Capsular repair, acetabular labral repair.

Device Description

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Arthrex SwiveLock Suture Anchor." This document largely focuses on the regulatory approval process and states that the device is substantially equivalent to existing predicate devices.

However, the text does not contain the detailed information required to answer your specific questions about acceptance criteria and the study that proves the device meets those criteria.

Here's why and what information is missing:

Acceptance Criteria and Reported Device Performance: The document states that "Cyclic pull-out testing after 16 weeks of degradation was conducted on the Arthrex SwiveLock Suture Anchor. Results demonstrate that the Arthrex SwiveLock Anchor performs statistically equivalent to the predicate device (K061863 – Arthrex Corkcrew)." It also mentions "Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications." However, it does not provide specific numerical acceptance criteria (e.g., minimum pull-out strength in Newtons) or the numerical reported performance data. Therefore, a table cannot be created.
Sample Size, Ground Truth, Adjudication, MRMC, Standalone Performance, Training Set Information: The document is completely silent on these aspects. These details are typically found in a more comprehensive study report or clinical trial summary, not usually in a 510(k) summary focused on substantial equivalence. The tests mentioned (cyclic pull-out, bacterial endotoxin) are mechanical and biological safety tests, not performance studies that would involve human readers, ground truth establishment, or large patient datasets.

In summary, based on the provided text, I cannot complete the requested information. The document confirms that testing was done to show equivalence and meet safety specifications, but it does not disclose the specifics of those tests, such as acceptance criteria values or detailed performance results, nor does it describe studies involving clinical performance evaluation as you've outlined.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION".

Arthrex Inc. David L. Rogers Manager, Regulatory Affairs 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K191226

Trade/Device Name: Arthrex SwiveLock Suture Anchor 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: June 10, 2019 Received: June 11, 2019

Dear Mr. Rogers:

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 (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 (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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Laurence D. Coyne, Ph.D. 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)

K191226

Device Name Arthrex SwiveLock Suture Anchor

Indications for Use (Describe)

The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ ankle, knee, hand/wrist, elbow, and hip 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, Midfoot 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 Ligament Reconstruction, Lateral Epicondylitis repair.

. Hip: Capsular repair, acetabular labral repair.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary or 510(k) Statement

Date Prepared	May 3, 2019
Submitter	Arthrex Inc.
	1370 Creekside Boulevard
	Naples, FL 34108-1945
Contact Person	David L Rogers
	Manager, Regulatory Affairs
	1-239-598-4302, ext. 71924
	David.rogers@arthrex.com
Name of Device	Arthrex SwiveLock Suture Anchor
Common Name	Suture Anchor
Product Code	MAI, MBI
Classification Name	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
	21 CFR 888.3030: Single/multiple component metallic bone fixation appliancesand accessories
Regulatory Class	II
Predicate Device	K180768: Arthrex SwiveLock Anchors
	K061863: Arthrex Corkscrew
Purpose ofSubmission	This traditional 510(k) premarket notification is submitted to obtain anteriorcruciate ligament repair indications for the Arthrex SwiveLock Anchors clearedunder K180768, K171141, and K151342.
Device Description	The Arthrex SwiveLock Anchor is a two-component, knotless suture anchorcomprised of an eyelet and a hollow anchor body. The SwiveLock Anchor ispremounted on a driver with the anchor body and eyelet physically separated onthe driver shaft. Arthrex 510(k) cleared suture may also be provided with thedevice.
Indications for Use	The Arthrex SwiveLock Suture Anchors are intended for fixation of suture (softtissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip inthe 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 TendonRepair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,Metatarsal Ligament Repair/Tendon Repair and Bunionectomy.
	Knee: Anterior Cruciate Ligament Repair (4.75-5.5 SwiveLock Only),Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair,Patellar Tendon Repair, Posterior Oblique Ligament Repair, IlliotibialBand Tenodesis, and Quadriceps Tendon Repair. Secondary or adjunctfixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only).
	Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction.
	Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar orRadial Collateral Ligament Reconstruction, Lateral Epicondylitis repair.
	Hip: Capsular repair, acetabular labral repair.
Performance Data	Cyclic pull-out testing after 16 weeks of degradation was conducted on theArthrex SwiveLock Suture Anchor. Results demonstrate that the Arthrex

Conclusion	SwiveLock Anchor performs statistically equivalent to the predicate device(K061863 – Arthrex Corkcrew).Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
	The Arthrex SwiveLock Anchor is substantially equivalent to the predicate devicein which the basic design features and intended uses are the same. Anydifferences between the proposed device and the predicate device areconsidered minor and do not raise questions concerning safety or effectiveness.
	Based on the indications for use, technological characteristics, and the summaryof data submitted, Arthrex Inc. has determined that the proposed device issubstantially equivalent to the currently marketed predicate devices.

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Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

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