# K203493: MectaLock Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Feb 22, 2021 after 87 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- 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: 7 generations back to K961555 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101679: Arthrex Pushlock Anchors, Arthrex, Inc. (2010) Summary page 4.

## Indications for use
The MectaLock PEEK Suture anchors (size 4.5, 5.5 & 6.5 mm) are intended for use in arthroscopic or open surgical approaches: • soft tissue refixation within the shoulder joint (i.e.: rotator cuff repair)

Source page: https://510kreport.com/device/K203493
Methodology: https://510kreport.com/methodology