FiberTak DR
510(k) K160319
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK160319 | Date10 May 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MBI
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The FiberTak DR is a suture anchor designed for orthopedic fixation in soft tissue repair. It provides secure attachment of tendons or ligaments to bone, particularly in procedures such as rotator cuff or biceps tendon reattachment, by anchoring sutures within the cortical bone.
This device is supplied as a single-use, sterile product and is intended for use in orthopedic surgical settings. It is compatible with MRI environments and comes in sizes corresponding to drill diameters of 1.6 mm, 1.7 mm, and 1.8 mm, with associated curved and straight guide delivery systems. The FiberTak DR holds FDA 510(k) clearance (K160319) under the Special 510(k) pathway for orthopedic applications.
Other devices from Arthrex, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of orthopedic procedures is the FiberTak DR suture anchor specifically designed for, and how does it work in those cases?
The FiberTak DR suture anchor is designed for soft tissue repair procedures like rotator cuff or biceps tendon reattachment, where tendons or ligaments need secure attachment to bone. It works by anchoring sutures within the cortical bone, providing a stable fixation point to reattach the tendon or ligament to the bone surface.
Is the FiberTak DR compatible with MRI machines, and why might that be important for patients?
Yes, the FiberTak DR is explicitly designed to be compatible with MRI environments. This is important because it allows patients to undergo MRI scans post-surgery without the need for removal of the anchor, reducing the risk of complications from a second procedure and enabling better monitoring of healing progress.
What sizes are available for the FiberTak DR suture anchor, and how do those sizes correspond to clinical use?
The FiberTak DR comes in three sizes corresponding to drill diameters of 1.6 mm, 1.7 mm, and 1.8 mm, which align with common cortical bone drilling practices in orthopedic surgery. These sizes accommodate varying bone densities and surgical needs, ensuring appropriate fixation strength for different tendon or ligament reattachment scenarios.
How is the FiberTak DR supplied, and what should clinicians consider regarding its sterility and reuse?
The FiberTak DR is supplied as a single-use, sterile product, meaning each device is intended for one surgical procedure only. Clinicians should follow standard sterile technique protocols during handling and implantation to maintain sterility. Reuse is not recommended or supported, as it could compromise patient safety and device integrity.
What delivery systems are included with the FiberTak DR, and how do they affect surgical flexibility?
The FiberTak DR is available with both curved and straight guide delivery systems, which provide surgeons with flexibility in how they approach the bone and tendon/ligament attachment site. The curved system may be advantageous for certain angles or anatomical constraints, while the straight system offers precision in more direct insertion paths.