# K960853: Ace System

- Pathway: 510(k) (Traditional)
- Applicant: Xomed, Inc.
- Decided: Apr 3, 1996 after 33 days
- Product code: EQJ (Bur, Ear, Nose And Throat)
- Device class: 1
- Regulation: 21 CFR 874.4140
- 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 K791407 (1979). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K791407: Womed Nicro-Craft Power System, Xomed, Inc. (1979) Summary page 2.
- K926547: Mednext 1000 Bone Dissecting System, Mednext, Inc. (1993) Summary page 2.
- (no number) Synergy™: named in the summary without a submission number
- (no number) Jedmed Otologic Drill: named in the summary without a submission number
- (no number) UltraPower™ Complete Drill System: named in the summary without a submission number

## Most influential descendants
- K983224: XPS Drill System (1998), 0 descendants of its own

## Indications for use
The ACE System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. It also has applications in neurosurgery (e.g. cervical laminectomies), hand surgery, and plastic surgery (e.g. facial and mandibular reconstruction)

Source page: https://510kreport.com/device/K960853
Methodology: https://510kreport.com/methodology