Who is the manufacturer of Arthrex FiberTak Suture Anchor?

Arthrex, Inc. filed the 510(k) submission for Arthrex FiberTak Suture Anchor (K221396).

What is the FDA product code for Arthrex FiberTak Suture Anchor?

MBI. It is classified under 21 CFR 888.3040 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for Arthrex FiberTak Suture Anchor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Arthrex FiberTak Suture Anchor?

Arthrex FiberTak Suture Anchor (K203268); Stryker ICONIX All Suture Anchor System (K133671).

Who can help prepare an FDA 510(k) submission like Arthrex FiberTak Suture Anchor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Arthrex FiberTak Suture Anchor

K221396 · Arthrex, Inc. · MBI · Dec 22, 2022 · Orthopedic

Device Facts

Record ID	K221396
Device Name	Arthrex FiberTak Suture Anchor
Applicant	Arthrex, Inc.
Product Code	MBI · Orthopedic
Decision Date	Dec 22, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3040
Device Class	Class 2
Attributes	Therapeutic

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, 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

Device Story

All-suture knotless anchor; used for soft tissue-to-bone fixation in orthopedic procedures (shoulder, foot/ankle, knee, hand/wrist, elbow, hip). Anchor consists of hollow braided polyester sheath with UHMWPE or UHMWPE/polyester blend suture components. Preloaded on disposable inserter; provided sterile for single use. Operated by surgeons in clinical/OR settings. Device provides mechanical fixation of soft tissue to bone; benefits patient by facilitating tendon/ligament repair and reconstruction.

Clinical Evidence

Bench testing only. Cyclic pull-out testing performed to compare subject device performance against predicate. Bacterial endotoxin testing conducted per EP 2.6.14/USP <85> to confirm compliance with pyrogen limit specifications.

Technological Characteristics

All-suture knotless anchor. Materials: Polyester yarn (sheath), UHMWPE or UHMWPE/polyester blend (sutures). Form factor: Hollow braided sheath preloaded on disposable inserter. Sterilization: Sterile, single-use. No electronic or software components.

Indications for Use

Indicated for soft tissue-to-bone fixation in shoulder, foot/ankle, knee, hand/wrist, elbow, and hip orthopedic procedures.

Regulatory Classification

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.

Predicate Devices

Arthrex FiberTak Suture Anchor (K203268)
Stryker ICONIX All Suture Anchor System (K133671)

Reference Devices

Arthrex FiberTak Suture Anchor (K200341)
Arthrex FiberTak Suture Anchor (K181769)
Arthrex SwiveLock Suture Anchor (K173845)

Related Devices

K230433 — Arthrex Knotless FiberTak Suture Anchor · Arthrex, Inc. · Mar 10, 2023
K231113 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · May 18, 2023
K250596 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · Mar 28, 2025
K232742 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · Nov 3, 2023
K181769 — Arthrex FiberTak Suture Anchor · Arthrex, Inc. · Sep 21, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ December 22, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Arthrex Inc. Kelsey Roberts Sr. Regulatory Affairs Specialist 1370 Creekside Boulevard Naples. Florida 34108 Re: K221396 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: November 28, 2022 Received: November 29, 2022 Dear Kelsey Roberts: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-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-regulatoryassistance/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, # Laura C. Rose -S Laura C. Rose, Ph.D. 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K221396 #### 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, 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) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------| | <input type="checkbox"/> 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." {3}------------------------------------------------ ## 510(k) Summary | Date Prepared | December 21, 2022 | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108-1945 | | Contact Person | Kelsey Roberts Sr. Regulatory Affairs Specialist 1-239-598-4302 Ext. 72257 Kelsey.Roberts@Arthrex.com | | Name of Device | Arthrex FiberTak Suture Anchor | | Common Name | Smooth or threaded metallic bone fixation fastener | | Product Code | MBI | | Classification Name | 21 CFR 888.3040: Smooth or threaded metallic bone fixation fastener | | Regulatory Class | II | | Predicate Devices | K203268: Arthrex FiberTak Suture Anchor K133671: Stryker ICONIX All Suture Anchor System | | Reference Devices | K200341: Arthrex FiberTak Suture Anchor K181769: Arthrex FiberTak Suture Anchor K173845: Arthrex SwiveLock Suture Anchor | | Purpose of Submission | This Traditional 510(k) premarket notification is submitted to obtain clearance for additional device models of Arthrex FiberTak Suture Anchor cleared under K203268. | | 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 braided sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The sutures components are made of ultra-high molecular weight polyethylene yarns or a polyblend of UHMWPE and polyester yarns. The anchor is preloaded on a disposable inserter and provided sterile for single 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, 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 | | Technological Comparison | The proposed devices are a line extension to the predicate device (K203268). The proposed and predicate devices have the same basic design, intended use, packaging, shelf-life, biocompatibility profile, manufacturing and sterilization processes. In comparison to the predicate device, the proposed modifications include minor dimensional changes to the sheath and repair suture. Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness. | | Performance Data | Cyclic pull-out testing was conducted on the proposed devices and submitted in this Traditional 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP <85> was conducted to demonstrate that the device meets pyrogen limit specifications. | | Conclusion | The Arthrex FiberTak suture anchor devices are substantially equivalent to the predicate device in which the basic design features, intended use, materials, manufacturing, and sterilization processes are the same. Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness. Based on the intended use, technological characteristics, review of published literature, and the test data submitted, Arthrex Inc. has determined that the proposed devices are substantially equivalent to the currently marketed predicate device. | {4}------------------------------------------------