# K243470: Fix2Lock (PEEK Self Punching)

- Pathway: 510(k) (Special)
- Applicant: Osteonic Co., Ltd.
- Decided: Dec 3, 2024 after 25 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: 10 generations back to K961555 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231322: Fix2Lock (PEEK Self Punching), Osteonic Co., Ltd. (2023) Summary page 5.

## Indications for use
Fix2Lock is intended use for fixation of soft tissue to bone, using suture, in the following procedure; Orthopedic surgery for shoulders, knees, foot/ankle, hand/wrist and elbow.

Source page: https://510kreport.com/device/K243470
Methodology: https://510kreport.com/methodology