# K040250: Bone-Lok HP Washer

- Pathway: 510(k) (Traditional)
- Applicant: Triage Medical, Inc.
- Decided: Mar 23, 2004 after 50 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.
No later device cites it as a predicate yet.
0 of 1 device 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 13.0mm Washer: named in the summary without a submission number
- (no number) Biomet Orthopedics Titanium Washer, 13mm: named in the summary without a submission number

## Indications for use
The BONE-LOK TM HP Washer is an accessory intended for use with the BONE-LOKTM HP Cannulated Helical Compression Anchor System, in the general management of fractures and reconstructive surgery.

Source page: https://510kreport.com/device/K040250
Methodology: https://510kreport.com/methodology