# K243712: WasherCap™ Mini Fixation System (Model 45)

- Pathway: 510(k) (Traditional)
- Applicant: Abanza Tecnomed S.L
- Decided: Jan 30, 2025 after 59 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: 12 generations back to K792022 (1979). 98 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203495: Arthrex SwiveLock Anchor, Arthrex, Inc. (2021) Summary page 5.
- K221135: X-Twist PEEK Suture Anchor, Parcus Medical, LLC (2022) Summary page 6.
- K212197: WasherCap Fixation System, Abanza Tecnomed S.L (2022) Summary page 6.

## Most influential descendants
- K253618: QuadLock™ Fixation System (2026), 0 descendants of its own

## Indications for use
WasherCap™ Mini Fixation System is intended for fixation of suture/tape (soft tissue) to bone in the shoulder, knee and hand/wrist, in skeletally mature pediatric and adult patients for the following procedures: * Knee: - Meniscal root repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - Meniscal transplant: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - ACL/PCL Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. - ACL Reconstruction: only with WasherCap™ Mini Fixation System 4.5mm size and using 2 non-absorbable UHMWPE 1.4mm tapes or 1 non-absorbable UHMWPE 2.2mm tape. * Shoulder: - Rotator Cuff Repair: using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes. * Hand/Wrist: - Triangular fibrocartilage complex (TFCC): only with WasherCap™ Mini Fixation System 3.5mm size and using non-absorbable UHMWPE USP 2-0 sutures or non-absorbable UHMWPE 1.4-2.2mm tapes.

Source page: https://510kreport.com/device/K243712
Methodology: https://510kreport.com/methodology