The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tend Transfers
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Capsular Repair, Acetabular Labral repair

Device Description

The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter.

AI/ML Overview

The provided text describes the Arthrex Knotless SutureTak Anchor and its substantial equivalence to predicate devices, focusing on its intended use and mechanical properties. However, it does not contain the detailed information required to answer the questions about acceptance criteria and a study proving the device meets those criteria, as typically found in an AI/software device submission.

The document primarily focuses on regulatory clearance for a physical medical device (an anchor) and relies on mechanical testing for performance. There is no mention of an algorithm, AI, or human reader performance.

Therefore, the following information cannot be extracted from the provided text:

A table of acceptance criteria and the reported device performance: While the document mentions "established minimum acceptance criteria for tensile (pull-out) strength," it does not provide the specific criteria values or the reported performance data in a table format.
Sample size used for the test set and the data provenance: Not applicable to this type of device submission which focuses on mechanical testing, not a "test set" in the context of an algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical anchor's mechanical performance is typically established through laboratory testing following engineering standards, not expert consensus on medical images or diagnoses.
Adjudication method for the test set: Not applicable.
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, as this is a physical device, not an AI algorithm assisting 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 (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" would be the results obtained from standardized mechanical tests.
The sample size for the training set: Not applicable. This is not a machine learning model.
How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance:

The document states:

"The mechanical testing demonstrates that the proposed device meets or exceeds the established minimum acceptance criteria for tensile (pull-out) strength for the desired indications."

This indicates that mechanical testing was performed, and the device's performance in terms of tensile (pull-out) strength met predefined criteria. However, the specific values for these criteria and the results are not detailed in the provided text.

Summary

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/20155 Page 1/2

Arthrex SPECIAL 510(k): Arthrex Knotless SutureTak Anchor

1 510(k) Summary of Safety and Effectiveness

Date Summary Prepared	January 17, 2012
Purpose of Submission	To obtain clearance of the Arthrex Knotless SutureTak Anchor devices.
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Christina FloresRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 1819Fax: 239/598.5508Email: christina.flores@arthrex.com
Trade Name	Knotless SutureTak Anchor
Common Name	fastener, fixation, nondegradable, soft tissue
Product Code - Classification Name	MBI - 21 CFR 888.3040 fastener, fixation, nondegradable, soft tissueHWC - 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastenerGAT - 21 CFR 878.5000: Nonabsorbable poly(ethylene terephthalate) surgical suture
Predicate Devices	K061863 Arthrex 3 mm PEEK SutureTak
Device Description and Intended Use	The Arthrex Knotless SutureTak Anchor is a tap-in ribbed suture anchor comprised of PEEK material and preloaded with UHMWPE looped suture and assembled to an insertion device. The proposed anchor is being offered in a 3 mm diameter.The Arthrex Knotless SutureTak Anchor is intended to be used for suture or soft tissue fixation to bone in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. These indications are identical to those cleared in K061863 with the exception of the removal of the Skull and Pelvis indications.The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament ReconstructionShoulder: Rotator Cuff Repairs, Bankart Repair, SLAP

Page 8 of 19

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120155 Page 2/2

Arthrex SPECIAL 510(k): Arthrex Knotless SutureTak Anchor

		Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair,Capsular Shift or Capsulolabral Reconstruction
	Hand/Wrist:	Scapholunate Ligament Reconstruction, CarpalLigament Reconstructions,Repair/Reconstruction of collateral ligaments,Repair of Flexor and Extensor Tendons at thePIP, DIP, and MCP joints for all digits, DigitalTendon Transfers
	Foot/Ankle:	Lateral Stabilization, Medial Stabilization,Achilles Tendon Repair, Metatarsal LigamentRepair, Hallux Valgus reconstruction, DigitalTendon Transfers, Mid-foot Reconstruction
	Knee:	Medial Collateral Ligament Repair, LateralCollateral Ligament Repair, Patellar TendonRepair, Posterior Oblique Ligament Repair,Iliotibial Band Tenodesis
	Hip:	Capsular Repair, Acetabular Labral repair
Substantial EquivalenceSummary	The Arthrex Knotless SutureTak Anchor is substantiallyequivalent to the predicate devices in which the basic featuresand intended uses are the same. Any differences between theKnotless SutureTak Anchor and the predicates are consideredminor and do not raise questions concerning safety andeffectiveness.
		The mechanical testing demonstrates that the proposed devicemeets or exceeds the established minimum acceptance criteria fortensile (pull-out) strength for the desired indications.
		Based on the indication for use, technological characteristics, andsummary of data submitted, Arthrex, Inc. has determined that theArthrex Knotless SutureTak Anchor is substantially equivalentto currently marketed predicate devices.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is black and the background is white.

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized abstract symbol resembling an eagle or bird in flight, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", arranged in a circular fashion.

FEB 1 7 2012

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

Arthrex, Inc. % Ms. Christina Flores 1370 Creekside Boulevard Naples, FL 34108-1945

Re: K120155

Trade/Device Name: Arthrex Knotless SutureTak Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI, HWC, GAT Dated: January 17th, 2012 Received: January 18th, 2012

Dear Ms. Flores:

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.

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Page 2 – Ms. Christina Flores

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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm.

Sincerely vours.

Erin L. Keith

Mark N. Melkerson Director Division of Surgical. Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Arthrex SPECIAL 510(k): Arthrex Knotless SutureTak Anchor

3 Indications for Use Form

Indications for Use

K120155 510(k) Number (if known): .

Device Name:

Arthrex Knotless SutureTak Anchor

Indications For Use:

The Arthrex Knotless SutureTak Anchor is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow:	Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
Shoulder:	Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Hand/Wrist:	Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers
Foot/Ankle:	Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee:	Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip:	Capsular Repair, Acetabular Labral repair

Prescription Use _ X _ AND/OR Over-The-Counter Use __

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

PAGE 1 of 1

Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of 1

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

PAGET OF TO

510(k) Number K120155

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.