K Number
K250596
Device Name
Arthrex FiberTak Suture Anchor
Manufacturer
Date Cleared
2025-03-28

(28 days)

Product Code
Regulation Number
888.3040
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures: • 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, Joint Capsule Closure • Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair
Device Description
The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.
More Information

No
The description focuses on the physical construction and intended use of a suture anchor, with no mention of AI or ML capabilities.

No.
The device is an anchor used for fixation of soft tissue to bone, which is a structural fixation device rather than one that treats disease or medical conditions.

No

The device is an all-suture knotless anchor intended for fixation of soft tissue to bone in various parts of the body during surgical procedures. Its intended use is for treatment and repair, not for diagnosing conditions.

No

The device description clearly states it is an "all-suture knotless anchor" constructed from physical materials (polyester, UHMWPE, nylon) and preloaded on a disposable inserter. This indicates a physical medical device, not a software-only one.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states the device is for "fixation of suture (soft tissue) to bone" in various anatomical locations. This is a surgical procedure performed directly on the patient's body.
  • Device Description: The description details a physical implant (suture anchor) made of polyester and UHMWPE, preloaded on an inserter. This is a medical device used in surgery, not a reagent or instrument used to test samples in vitro (outside the body).
  • Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The performance studies focus on mechanical properties (pull-out strength) and sterility, not diagnostic accuracy.

In summary, the Arthrex FiberTak Suture Anchor is a surgical implant used for tissue repair, which falls under the category of a medical device, not an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

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

  • 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 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, Joint Capsule Closure
  • Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

Product codes

MBI

Device Description

The Arthrex FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Shoulder, foot/ankle, knee, hand/wrist, elbow, and hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Cyclic pull-out testing was conducted on the subject Arthrex FiberTak Suture Anchor submitted in this Special 510(k). The test data demonstrates that the subject device performs statistically equivalent to the primary predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K221396

Reference Device(s)

K230433, K193157

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

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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 logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The logo is simple and professional, and it is easily recognizable.

March 28, 2025

Arthrex Inc. Ruth Segall Regulatory Affairs Specialist II 1370 Creekside Blvd Naples, Florida 34108

Re: K250596

Trade/Device Name: Arthrex FiberTak Suture Anchor Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: MBI Dated: February 27, 2025 Received: February 28, 2025

Dear Ruth Segall:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Advice (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-regulatory

2

assistance/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,

Thomas Mcnamara -S

For: Christopher Ferreira, MS 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

3

Indications for Use

Submission Number (if known)

K250596

Device Name

Arthrex FiberTak Suture Anchor

Indications for Use (Describe)

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

  • 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 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, Joint Capsule Closure

· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon 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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Image /page/4/Picture/0 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a sans-serif font, with the "x" stylized to resemble a surgical instrument. The logo is simple and modern, and it is likely used to promote the company's products and services.

510(k) Summary

Date Prepared02/27/2025
SubmitterArthrex Inc.
1370 Creekside Boulevard
Naples, FL 34108-1945
Contact PersonName: Ruth Segall
Title: Regulatory Affairs Specialist II
Phone: 239-598-4302 x 71764
Email: Ruth.Segall@arthrex.com
Trade NameArthrex FiberTak Suture Anchor
Common NameSuture Anchor
Product CodeMBI
Classification Name21 CFR 888.3040: Smooth or threaded metallic bone
fixation fastener
Regulatory ClassClass II
Primary Predicate DeviceK221396: Arthrex FiberTak Suture Anchor
Additional Predicate DevicesN/A
Reference DevicesK230433: Arthrex Double Loaded Knotless FiberTak®
Suture Anchor
K193157: Arthrex 3.9 Corkscrew Suture Anchor
Purpose of SubmissionThis Special 510(k) premarket notification is submitted
to obtain clearance for the subject Arthrex FiberTak
Suture Anchor as a line extension to the Arthrex
FiberTak Suture Anchor cleared via K221396.
Device DescriptionThe Arthrex FiberTak Suture Anchor is an all-suture
knotless anchor intended to be used for fixation of
suture (soft tissue) to bone in the shoulder, foot/ankle,
knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid sheath
made of polyester yarns with Arthrex suture
components assembled to the sheath. The suture
components include a repair suture and a passing
suture which are braided polyester sutures made of
ultra-high molecular weight polyethylene (UHMWPE) |
| | where the suture may also include nylon yarns. The
anchor is preloaded on a disposable inserter and
is provided sterile (Ethylene Oxide), single-use, and is
packaged in a 5-pack. |
| Indications for Use | The Arthrex FiberTak Suture Anchor is intended for
fixation of suture (soft tissue) to bone in the shoulder,
foot/ankle, knee, hand/wrist, elbow, and hip in the
following procedures:
• 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, Joint Capsule Closure
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal
Tendon Repair |
| Performance Data | Cyclic pull-out testing was conducted on the subject
Arthrex FiberTak Suture Anchor submitted in this
Special 510(k). The test data demonstrates that the
subject device performs statistically equivalent to the
primary predicate device.
Bacterial endotoxin per EP 2.6.14/USP was
conducted to demonstrate that the device meets
pyrogen limit specifications. |
| Technological Comparison | The subject Arthrex FiberTak Suture Anchor is a line
extension to the primary predicate device K221396. The
subject and primary predicate devices have identical
basic design, indications for use, intended use,
packaging, shelf-life, biocompatibility profile, overall
manufacturing, and sterilization processes. In
comparison to the predicate device, the subject device
contains a modification to the pre-loaded sutures. Any
differences between the subject and predicate devices
are considered minor and do not raise any questions
concerning safety or effectiveness. |
| Conclusion | The Arthrex FiberTak Suture Anchor is a line extension
and substantially equivalent to the predicate device
(K221396) in which the basic design features,
indications for use and intended use are identical. Any
differences between the subject device and the primary
predicate devices are considered minor and do not
result in new or different questions concerning safety or
effectiveness. Based on the indications for use,
technological characteristics, and the summary of data
submitted, Arthrex has determined that the subject
device is substantially equivalent to the currently
marketed primary predicate device. |

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Image /page/5/Picture/1 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the text is an image of a surgical instrument, possibly a type of clamp or forceps. The instrument is stylized and simplified, with a handle and a grasping end.

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Image /page/6/Picture/1 description: The image shows the logo for Arthrex. The logo consists of the word "Arthrex" in a bold, sans-serif font. To the right of the word is an image of a surgical tool, possibly a type of clamp or scissor. The logo is simple and professional, and it is likely used to represent the company's brand.