# K212197: WasherCap Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Abanza Tecnomed S.L
- Decided: Sep 22, 2022 after 435 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: 3 generations back to K922559 (1992). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130217: Orthopediatrics Acl Reconstructive System, OrthoPediatrics Corp. (2013) Summary page 4.

## Most influential descendants
- K243712: WasherCap™ Mini Fixation System (Model 45) (2025), 1 descendant of its own
- K253618: QuadLock™ Fixation System (2026), 0 descendants of its own
- K250238: WasherCap™ Fixation System (2025), 0 descendants of its own

## Indications for use
WasherCap TM 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/K212197
Methodology: https://510kreport.com/methodology