# K965028: Acumed Suture Washer

- Pathway: 510(k) (Traditional)
- Applicant: Acu Med, Inc.
- Decided: Mar 17, 1997 after 90 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.
4 later devices descend from it; 2 cite it directly.
0 of 5 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) Linvatec Spiked Washer: named in the summary without a submission number

## Most influential descendants
- K990392: Depuy Ace Spider Plate (1999), 2 descendants of its own
- K111663: Trauma Internal Fixation Systems (2012), 1 descendant of its own
- K243761: A.L.P.S. Small Fragment Plating System (2025), 0 descendants of its own
- K984458: Depuy Ace Spider Plate (1998), 0 descendants of its own

## Indications for use
The Acumed Suture Washer is intended for soft tissue fixation, small bone fixation, and large bone fixation and may be used in conjunction with a 3.5mm or 4.0mm titanium bone screw and suture. This device is not intended for usage in the spine.

Source page: https://510kreport.com/device/K965028
Methodology: https://510kreport.com/methodology