The Arthrex Corkscrew suture anchors are intended to be used 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 Repair, Bankart 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 and Bunionectomy.
Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
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, gluteus medius repair.

The Arthrex SwiveLock 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, 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 and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.
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, gluteus medius repair.

Device Description

The Arthrex Corkscrew and SwiveLock Suture Anchors consist of cannulated anchors manufactured from polyetheretherketone (PEEK) or Titanium with an integral or separate eyelet. They are pre-loaded on a handled inserter. Suture, with or without needles, and a suture threader may also be provided.

AI/ML Overview

This document is a 510(k) premarket notification for Arthrex Corkscrew and SwiveLock Suture Anchors. It outlines the summary of safety and effectiveness, but it does not describe an acceptance criteria table or a study that proves the device meets specific performance criteria in the way requested for AI/software devices.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on design features, intended use, and mechanical testing.

Therefore, I cannot directly extract the exact information requested in the prompt's numbered list regarding acceptance criteria and a study proving their fulfillment as this is not a clinical study report for an AI/software device.

However, I can provide information based on the type of evidence presented in this 510(k) summary:

Acceptance Criteria & Device Performance: This document does not present specific acceptance criteria in a tabular format with corresponding device performance metrics for a clinical or AI-based assessment. Instead, it relies on demonstrating that the new devices perform comparably to the predicate devices through mechanical testing. The implication is that if the new device performs similarly in these mechanical tests to an already cleared device, it "meets acceptance criteria" for substantial equivalence.

Acceptance Criteria (Implied by equivalence)	Reported Device Performance (Implied by equivalence)
Biocompatibility	Deemed acceptable (not explicitly stated here, but typically required for medical devices)
Mechanical strength (e.g., pull-out strength)	Demonstrated to be substantially equivalent to predicate devices through insertion testing, static pull-out testing, fatigue testing, and suture abrasion testing data. Specific numerical results are not provided in this summary.
Device functionality	Deemed substantially equivalent to predicate devices.

Sample size used for the test set and the data provenance: Not applicable in the context of clinical/AI test sets. The "test set" here refers to the physical devices undergoing mechanical testing. The provenance of these devices would be from the manufacturer (Arthrex), and the testing would be conducted in a lab environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the AI/clinical sense, is not established for this type of submission. The "truth" is based on the physical properties and performance of the devices as measured in mechanical tests.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This is a submission for a physical medical device (suture anchors), not an AI/software product that assists human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used: For this physical device, the "ground truth" is established through mechanical testing data (insertion testing, static pull-out testing, fatigue testing, and suture abrasion testing). These tests provide objective measurements of the device's physical and mechanical properties.
The sample size for the training set: Not applicable. This document pertains to physical medical devices, not AI/machine learning algorithms that require training sets.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission successfully demonstrates substantial equivalence by comparing the new Arthrex Corkscrew and SwiveLock Suture Anchors to previously cleared predicate devices through direct comparison of design features, intended uses, and results from mechanical performance tests. It does not involve AI, clinical efficacy studies with human readers, or a ground truth established by expert consensus on clinical cases.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 2, 2015

Arthrex, Incorporated Mr. David Rogers Regulatory Affairs Associate 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K143745

Trade/Device Name: Arthrex Corkscrew and SwiveLock Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: May 12, 2015 Received: May 14, 2015

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -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)

K143745

Device Name Arthrex Corkscrew Suture Anchors

Indications for Use (Describe)

The Arthrex Corkscrew suture anchors are intended to be used 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 Repair, Bankart 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 and Bunionectomy.

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

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, gluteus medius 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Indications for Use

510(k) Number (if known)

K143745

Device Name Arthrex SwiveLock Suture Anchors

Indications for Use (Describe)

The Arthrex SwiveLock 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, 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 and Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis.

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, gluteus medius 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510K SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	June 30, 2015
Manufacturer/Distributor/	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
Sponsor	Naples, FL 34108-1945 USA
510(k) Contact	David L RogersRegulatory AffairsArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71924Fax: 239/598.5508Email: david.rogers@arthrex.com
Trade Name	Arthrex Corkscrew and SwiveLock Suture Anchors
Common Name	Suture Anchor
Product Code,	MBI
Classification Name, CFR	21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener
Predicate Device	K113294: HEALICOIL PK Suture AnchorK101823: Arthrex SwiveLock AnchorsK061863: Arthrex Corkscrew, Corkscrew FT, Bio-Corkscrew, and Bio Corkscrew FTSuture Anchors
Purpose of Submission	This traditional 510(k) premarket notification is submitted to obtain clearance forthe Arthrex Corkscrew and SwiveLock Suture Anchors for gluteus medius repair inthe hip.
Device Description	The Arthrex Corkscrew and SwiveLock Suture Anchors consist of cannulatedanchors manufactured from polyetheretherketone (PEEK) or Titanium with anintegral or separate eyelet. They are pre-loaded on a handled inserter. Suture,with or without needles, and a suture threader may also be provided.
Intended Use	The Arthrex Corkscrew suture anchors are intended to be used for fixation ofsuture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, andelbow 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 TendonRepair, Hallux Valgus Reconstruction, Mid-foot Reconstruction,Metatarsal Ligament Repair/Tendon Repair and Bunionectomy. Knee: Anterior Cruciate Ligament Repair, Medial Collateral LigamentRepair, Lateral Collateral Ligament Repair, Patellar Tendon Repair,Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. 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, gluteus medius repair.
	The Arthrex SwiveLock anchors are intended for fixation of suture (soft tissue) tobone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in thefollowing 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: Medial Collateral Ligament Repair, Lateral Collateral Ligament
	Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, andIlliotibial Band Tenodesis.
•	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, gluteus medius repair.
SubstantialEquivalence Summary	The Arthrex Corkscrew and SwiveLock Suture Anchors is substantially equivalentto the predicate devices, in which the basic design features and intended uses arethe same. Any differences between the Arthrex Corkscrew and SwiveLock SutureAnchors and the predicates are considered minor and do not raise questionsconcerning safety and effectiveness.
	The submitted insertion testing, static pull-out testing, fatigue testing, and sutureabrasion testing data demonstrates that the proposed devices are substantiallyequivalent to the predicates.
	Based on the indication for use, technological characteristics, and the summary ofdata submitted, Arthrex, Inc. has determined that the Arthrex Corkscrew andSwiveLock Suture Anchors is substantially equivalent to currently marketedpredicate devices.

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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.