# K983265: Depuy Ace Composite Locking Nut

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Ace Medical Co.
- Decided: Oct 26, 1998 after 39 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 K874669 (1987). 2 ancestors in all.
136 later devices descend from it; 1 cites it directly.
1 of 139 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K874669: Ace Bone Screw Nut, Buckman Co., Inc. (1987) Summary page 1.
- K895107: Ace Orthopaedic Washers, Buckman Co., Inc. (1989) Summary page 1.

## Most influential descendants
- K112885: Zimmer Plates and Screws System Screws Only (2011), 135 descendants of its own
- K143039: CrossRoads Screw System (2015), 79 descendants of its own
- K162825: CAPTIVATE™ Compression Screws (2017), 74 descendants of its own
- K171651: Excelsius GPS (2017), 69 descendants of its own
- K191100: ExcelsiusGPS Spine 1.1 Interbody Module (2019), 42 descendants of its own

## Indications for use
The DePuy ACE Composite Locking Nut is used as follows: Cortical bone screws (alone) Intramedullary nails as locking bolts Screws with plates Where extra purchase in far cortex is required

Source page: https://510kreport.com/device/K983265
Methodology: https://510kreport.com/methodology