# K203335: MectaScrew Extension

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Feb 3, 2022 after 448 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 10 generations back to K933738 (1994). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071437: Megafix-C  Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C, KARL STORZ Endoscopy-America, Inc. (2007) Summary page 4.
- K190892: MectaScrew PEEK Interference Screw, Medacta International S.A. (2019) Summary page 4.

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

Source page: https://510kreport.com/device/K203335
Methodology: https://510kreport.com/methodology