# K924455: Synthes (Usa) Titanium Locked Spiked Washer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: May 12, 1993 after 252 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013806: Synthes Metallic Spiked Washers (2002), 5 descendants of its own
- K200028: Coronet Soft Tissue Fixation System (2020), 2 descendants of its own
- K220966: Sinefix (2023), 1 descendant of its own
- K254176: Sinefix (2026), 0 descendants of its own
- K132510: Biopro - Infinity Plate Anchor System (2013), 0 descendants of its own

Source page: https://510kreport.com/device/K924455
Methodology: https://510kreport.com/methodology