The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:
• Shoulder: Rotator Cuff Repairs, 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, Bunionectomy.
• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, 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 Corkscrew FT is a fully threaded, vented suture anchor pre-loaded with Arthrex Suture on a disposable inserter. The anchor is manufactured from PLLA/BTCP and is offered sterile.

AI/ML Overview

The provided text describes the Arthrex Corkscrew FT, a medical device for suture/soft tissue fixation to bone. The submission is a Special 510(k) to add a line extension to cleared BioComposite Suture Anchors. The performance data focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for acceptance criteria of a novel AI/software device. Therefore, much of the requested information regarding AI device evaluation (e.g., expert consensus, MRMC studies, training/test set sample sizes for AI, adjudication methods) is not applicable or cannot be extracted from this document.

However, I can extract the acceptance criteria and the study performed in the context of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Pull-out force equivalent to the predicate after 26 weeks degradation.	Tensile testing demonstrated that the pull-out force of the device is equivalent to the predicate.
Meets pyrogen limit specifications.	Bacterial endotoxin testing per EP 2.6.14/USP <85> demonstrated that the device meets pyrogen limit specifications.

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

Test Set Sample Size: Not specified for tensile testing. For bacterial endotoxin, sample size is typically dictated by the test method (e.g., a specific number of devices or extracts are tested).

Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are performance tests conducted on the device itself.

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

Not applicable. This device is a physical medical implant, and its performance (tensile strength, pyrogenicity) is evaluated through objective lab testing, not human expert interpretation of data like in AI/imaging devices.

4. Adjudication method for the test set

Not applicable. Adjudication methods are typically used for establishing ground truth in human-interpreted data, such as in clinical trials or AI performance evaluations, not for physical material testing.

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 submission is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This device is a physical medical implant, not an algorithm.

7. The type of ground truth used

The "ground truth" here is the objective measurement of physical properties:

Tensile Strength/Pull-out Force: Measured directly through mechanical testing. The benchmark for equivalence is the performance of the legally marketed predicate device (K082810: Arthrex BioComposite Suture Anchors, and K061665: Arthrex Corkscrew FT).
Pyrogenicity: Measured through standard bacterial endotoxin testing (EP 2.6.14/USP <85>) against established pyrogen limit specifications.

8. The sample size for the training set

Not applicable. Training sets are relevant for machine learning models, not for traditional physical device testing.

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

Not applicable. See point 8.

Summary

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

March 1, 2018

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

Re: K173788

Trade/Device Name: Arthrex Corkscrew FT Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI Dated: January 29, 2018 Received: January 30, 2018

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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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1000-1050.

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

Vincent J. Devlin -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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Indications for Use

510(k) Number (if known) K173788

Device Name Arthrex Corkscrew FT

Indications for Use (Describe)

The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the following procedures:

. Shoulder: Rotator Cuff Repairs, 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, Bunionectomy.
. Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
. Hand/Wrist: Scapholunate Ligament Reconstruction, Unar or Radial Collateral Ligament Reconstruction, 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)

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

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510(k) Summary

Date Prepared	February 27, 2018
Submitter	Arthrex Inc.1370 Creekside BoulevardNaples, FL 34108-1945
Contact Person	David L RogersProject Manager, Regulatory Affairs1-239-643-5553, ext. 71924david.rogers@arthrex.com
Name of Device	Arthrex Corkscrew FT
Common Name	Suture Anchor
Product Code	MAI
Classification Name	21 CFR 888.3030: Fastener, Fixation, Biodegradable, Soft Tissue
Regulatory Class	II
Predicate Device	K082810: Arthrex BioComposite Suture AnchorsK061665: Arthrex Corkscrew FT
Purpose of Submission	This Special 510(k) premarket notification is submitted to add a line extension tothe Arthrex BioComposite Anchors cleared under predicate K082810.
Device Description	The Arthrex Corkscrew FT is a fully threaded, vented suture anchor pre-loadedwith Arthrex Suture on a disposable inserter. The anchor is manufactured fromPLLA/BTCP and is offered sterile.
Indications for Use	The Arthrex Corkscrew FT is intended for fixation of suture (soft tissue) to bone inthe shoulder, foot/ankle, hip, knee, hand/wrist, and elbow in the followingprocedures:• Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, BicepsTenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, CapsularShift or Capsulolabral Reconstruction.• Foot/Ankle:Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair,Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal LigamentRepair/Tendon Repair, Bunionectomy.• Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair,Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band Tenodesis.• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or RadialCollateral Ligament Reconstruction, Radial Collateral LigamentReconstruction.• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radialcollateral Ligament Reconstruction, Lateral Epicondylitis Repair.• Hip: Capsular Repair, acetabular labral repair.
Performance Data	Tensile testing was conducted after 26 weeks degradation to demonstrate thatthe pull-out force of the device is equivalent to the predicate.Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate thatthe device meets pyrogen limit specifications.
Conclusion	Arthrex Corkscrew FT is substantially equivalent to the predicate device in whichthe basic design features and intended uses are the same. Any differencesbetween the proposed device and the predicate device are considered minor anddo 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 Arthrex Corkscrew FT issubstantially equivalent to the currently marketed predicate device.

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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.