# K011583: Spiked Washer

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 30, 2002 after 252 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
30 later devices descend from it; 3 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes (USA) Spiked Washer: named in the summary without a submission number

## Most influential descendants
- K033303: Wafer System (2004), 23 descendants of its own
- K053336: Staxx FX System (2006), 12 descendants of its own
- K063606: Modification to Staxx FX System (2007), 11 descendants of its own
- K132817: Kiva VCF Treatment System (2014), 9 descendants of its own
- K052670: Staxx XD System (2006), 8 descendants of its own

## Recalls of this device
- Oct 3, 2013 · Class II · Z-0394-2014: During a retrospective assessment, Spiked Washers 13.5/6.5 were discovered to be mislabeled as Spiked Washers 13.5/5.5.

## Indications for use
Synthes Spiked Washer is intended for use in ligament reattachment or fixation, specifically readaptation of torn or avulsed ligaments.

Source page: https://510kreport.com/device/K011583
Methodology: https://510kreport.com/methodology