# K250238: WasherCap™ Fixation System

- Pathway: 510(k) (Special)
- Applicant: Abanza Tecnomed S.L
- Decided: Feb 25, 2025 after 29 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 K922559 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212197: WasherCap Fixation System, Abanza Tecnomed S.L (2022) Summary page 5.

## Indications for use
WasherCap™ Fixation System is intended for fixation of soft tissue grafts, including tendons and ligaments, during surgical procedures such as in Anterior Cruciate Ligament (ACL) reconstruction of the knee.

Source page: https://510kreport.com/device/K250238
Methodology: https://510kreport.com/methodology