# K243624: Acu-Sinch Knotless Mini

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Jan 23, 2025 after 59 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K792022 (1979). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140328: CMC Mini Tightrope, Arthrex, Inc. (2014) Summary page 5.

## Indications for use
Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

Source page: https://510kreport.com/device/K243624
Methodology: https://510kreport.com/methodology