# K202763: Fix2Lock (PEEK Self Punching)

- Pathway: 510(k) (Traditional)
- Applicant: Osteonic Co., Ltd.
- Decided: Jun 4, 2021 after 256 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: 8 generations back to K961555 (1996). 11 ancestors in all.
2 later devices descend 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)
- K143745: Arthrex Corkscrew and SwiveLock Suture Anchors, Arthrex, Inc. (2015) Summary page 5.

## Most influential descendants
- K231322: Fix2Lock (PEEK Self Punching) (2023), 1 descendant of its own
- 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 and knees.

Source page: https://510kreport.com/device/K202763
Methodology: https://510kreport.com/methodology