# K190474: MectaLock PEEK Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: May 28, 2019 after 90 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: 4 generations back to K961555 (1996). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061863: Arthrex Corkscrew Suture Anchor, Tak, and Pushlock Family, Arthrex, Inc. (2006) Summary page 4.

## Indications for use
The MectaLock PEEK Suture anchors are intended for use in arthroscopic or open surgical approaches for fixation of suture (soft tissue) to bone in the shoulder and hip in the following procedures: • Hip: acetabular labral repair; and • Shoulder: glenoid labrum repair.

Source page: https://510kreport.com/device/K190474
Methodology: https://510kreport.com/methodology