FiberTak DR is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
• Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• 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

Device Description

FiberTak DR is an "all-suture" soft-tissue fixation device with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around or though soft tissue and tied in a knot; or the repair can be completed in a knotless fashion when used in combination with Arthrex SwiveLock Anchors (K101823). FiberTak DR is constructed from a hollow braid of polyester with a suture component combination assembled through the hollow braid. The suture component can be made from either UHWMPE or a polyblend of UHMWPE and Polyester. The anchor configuration of FiberTak DR is similar to the predicate device, except that it combines suture and tape within the same anchor. FiberTak DR is available in three models with combinations in the color of its suture components. FiberTak DR comes preloaded on a disposable inserter made from stainless steel (ASTM F899) whereas the predicate inserter is made of nitinol. The handle of the inserters is made of ABS plastic. FiberTak DR may be sold separately or in a kit with implantation instrumentation. The proposed FiberTak DR is provided sterile for single use.

AI/ML Overview

The provided document is a 510(k) premarket notification for the FiberTak DR device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through clinical studies or extensive performance testing with pre-defined thresholds.

Therefore, the document does not contain the following information typically associated with acceptance criteria and a study proving a device meets them:

A table of acceptance criteria and the reported device performance: While mechanical testing is mentioned, specific acceptance criteria and detailed performance results are not provided in this summary.
Sample sized used for the test set and the data provenance: Not explicitly stated for performance testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is a device performance submission, not a diagnostic accuracy study.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as this is a device performance submission, not a diagnostic accuracy study or an AI-assisted interpretation study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable in the context of this device's performance testing.
The sample size for the training set: Not applicable (no AI/algorithm training set).
How the ground truth for the training set was established: Not applicable.

What is stated in the document regarding how the device meets regulatory requirements:

The submission focuses on demonstrating substantial equivalence to a predicate device (K151230: Arthrex FiberTak Anchors) based on:

Similar basic design features (all-suture anchor).
Similar materials.
Similar intended use.
Mechanical testing: "The submitted mechanical testing demonstrates that the pull-out strength of the proposed FiberTak DR exceeds the pull out strength of the predicate device. In addition, the pull out displacements recorded meet the criteria established by the predicate devices and therefore of no clinical relevance."
Biocompatibility and packaging/shelf life: Determined acceptable due to similarities in material and packaging with the predicate device.

In summary, the FDA's clearance is based on the finding that the FiberTak DR is substantially equivalent to existing devices, primarily supported by comparative mechanical testing showing its performance is at least equivalent to, if not exceeding, that of the predicate device. The document does not detail specific acceptance numeric thresholds, but rather implies that performance equivalent to a previously cleared device is the "acceptance criterion" for this type of submission.

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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.

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

May 10, 2016

Arthrex, Incorporated Ms. Ivette Galmez Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108-1945

Re: K160319

Trade/Device Name: FiberTak DR Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 20, 2016 Received: April 21, 2016

Dear Ms. Galmez:

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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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" (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 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,

Mark N. Melkerson -S

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 2.5

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160319

Device Name

FiberTak DR

Indications for Use (Describe)

FiberTak DR is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:

· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

· Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

· 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

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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2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

Date Summary Prepared	April 12, 2016
Manufacturer/Distributor/Sponsor	Arthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USA
510(k) Contact	Ivette GalmezRegulatory Affairs SpecialistArthrex, Inc.1370 Creekside BoulevardNaples, FL 34108-1945 USATelephone: 239/643.5553, ext. 71263Fax: 239/598.5508Email: igalmez@arthrex.com
Trade Name	FiberTak DR
Common Name	Soft Tissue Fixation Device
Product Code -Classification NameCFR	MBIFastener, fixation, nondegradable, soft tissue21 CFR 888.3040
Predicate Device	K151230: Arthrex FiberTak Anchors
Purpose of Submission	This special 510(k) premarket notification is submitted to obtainclearance for FiberTak DR.
Device Description	FiberTak DR is an "all-suture" soft-tissue fixation device with anexpandable push-in design. The anchor and connected suturesare impacted into a pilot hole. The sutures are then manuallytensioned to set the anchor by "bulging" the suture sleeve withinthe pilot hole. Once the anchor is set, the suture is passedaround or though soft tissue and tied in a knot; or the repair canbe completed in a knotless fashion when used in combinationwith Arthrex SwiveLock Anchors (K101823).FiberTak DR is constructed from a hollow braid of polyester witha suture component combination assembled through the hollowbraid. The suture component can be made from either UHWMPEor a polyblend of UHMWPE and Polyester. The anchorconfiguration of FiberTak DR is similar to the predicate device,except that it combines suture and tape within the same anchor.FiberTak DR is available in three models with combinations in thecolor of its suture components. FiberTak DR comes preloaded ona disposable inserter made from stainless steel (ASTM F899)whereas the predicate inserter is made of nitinol. The handle ofthe inserters is made of ABS plastic. FiberTak DR may be soldseparately or in a kit with implantation instrumentation. Theproposed FiberTak DR is provided sterile for single use.
Intended Use	FiberTak DR is intended to be used for suture or tissue fixation inthe foot/ankle, knee, hand/wrist, elbow, and shoulder. Specificindications are listed below:
	• Elbow: Biceps Tendon Reattachment, Ulnar or Radial CollateralLigament Reconstruction
	• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP LesionRepair, Biceps Tenodesis, Acromio-Clavicular SeparationRepair, Deltoid Repair, Capsular Shift or CapsulolabralReconstruction
	• Hand/Wrist: Scapholunate Ligament Reconstruction,Repair/Reconstruction of collateral ligaments, Repair of Flexorand Extensor Tendons at the PIP, DIP and MCP joints for alldigits, digital tendon transfers, Carpal Ligament Reconstructionand Carpometacarpal joint arthroplasty (basal thumb jointarthroplasty)
	• Foot/Ankle: Lateral Stabilization, Medial Stabilization, AchillesTendon Repair, Metatarsal Ligament Repair, Hallux Valgusreconstruction, digital tendon transfers, Mid-footreconstruction
	• Knee: Medial Collateral Ligament Repair, Lateral CollateralLigament Repair, Patellar Tendon Repair, Posterior ObliqueLigament Repair, Iliotibial Band Tenodesis
Substantial EquivalenceSummary	The proposed FiberTak DR is similar to the predicate device inwhich the basic design features (all-suture anchor); the materialsand intended use are the same.
	The submitted mechanical testing demonstrates that the pull-outstrength of the proposed FiberTak DR exceeds the pull outstrength of the predicate device. In addition, the pull outdisplacements recorded meet the criteria established by thepredicate devices and therefore of no clinical relevance.Furthermore, the biocompatibility and packaging/shelf life forthe subject device were reviewed and determined to beacceptable due to its similarities in material and packaging.Based on the indication for use, technological characteristics, andthe summary of data submitted, Arthrex, Inc. has determinedthat FiberTak DR is substantially equivalent to currently marketed
	predicate 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.