# K190892: MectaScrew PEEK Interference Screw

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Jun 4, 2019 after 60 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: 6 generations back to K961555 (1996). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083635: Smith & Nephew Biosure PK Interference Screw, Smith & Nephew Endoscopy, Inc. (2009) Summary page 4.

## Most influential descendants
- K203335: MectaScrew Extension (2022), 0 descendants of its own

## Indications for use
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allo- grafts.

Source page: https://510kreport.com/device/K190892
Methodology: https://510kreport.com/methodology