# K231322: Fix2Lock (PEEK Self Punching)

- Pathway: 510(k) (Special)
- Applicant: Osteonic Co., Ltd.
- Decided: Jun 7, 2023 after 30 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: 9 generations back to K961555 (1996). 12 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202763: Fix2Lock (PEEK Self Punching), Osteonic Co., Ltd. (2021) Summary page 4.

## Most influential descendants
- K243470: Fix2Lock (PEEK Self Punching) (2024), 0 descendants of its own

## 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/K231322
Methodology: https://510kreport.com/methodology