# K013806: Synthes Metallic Spiked Washers

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Feb 8, 2002 after 85 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
Longest line of descent: 1 generation back to K914472 (1991). 2 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914472: Spiked Washer, Synthes (Usa) (1991) Summary page 3.
- K924455: Synthes (Usa) Titanium Locked Spiked Washer, Synthes (Usa) (1993) Summary page 3.

## Most influential descendants
- 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
- K111008: Microware Bone Plates and Bone Screw (2012), 0 descendants of its own

## Indications for use
The Metallic spiked washers are indicated for ligament reattachment or fixation.

Source page: https://510kreport.com/device/K013806
Methodology: https://510kreport.com/methodology