# K230595: OsteoCentric ACL Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: OsteoCentric Technologies
- Decided: Jun 29, 2023 after 118 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 2 generations back to K933352 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182955: EZStart Interference Screw, Conmed Corporation (2019) Summary page 4.
- K052607: Arthrex Interference Screw-Rounded Head Screws, Full Threaded Screws, Sheathed Cannulated Interference Screws, Arthrex, Inc. (2005) Summary page 4.

## Indications for use
The OsteoCentric ACL Fixation Fasteners are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.

Source page: https://510kreport.com/device/K230595
Methodology: https://510kreport.com/methodology