# K132461: A.I.M. Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Anchor Innovation Medical, Inc.
- Decided: Oct 16, 2013 after 70 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: 5 generations back to K961555 (1996). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007)
- K030995: Minilok Quickanchor Plus, Mitek Worldwide (2003) Summary page 1.

## Indications for use
The A.I.M.TM Suture Anchor is intended for use in arthroscopic, mini-open or open surgical procedures for fixation of soft tissue to bone. The A. I.M. TM Suture Anchor is intended for use in the following applications: Ankle: Mid-foot Reconstruction Foot: Hallux valgus reconstruction Hand: Ulnar or lateral collateral ligament reconstruction Wrist: Scapholunate ligament reconstruction

Source page: https://510kreport.com/device/K132461
Methodology: https://510kreport.com/methodology