# K082729: Rimclose Bone Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Anulex Technologies, Inc.
- Decided: Dec 19, 2008 after 92 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K971723 (1997). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971723: Fastak Suture Anchor (11.7MM)/(7.5MM), Arthrex, Inc. (1997) Summary page 1.

## Indications for use
The Rimclose Bone Anchor is intended for fixation of suture to bone. This product is intended for the following indications: Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Source page: https://510kreport.com/device/K082729
Methodology: https://510kreport.com/methodology