# K981526: Ace Alveolar Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Nov 6, 1998 after 192 days
- Product code: JEY (Plate, Bone)
- Device class: 2
- Regulation: 21 CFR 872.4760
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The ACE Surgical Alveolar Distraction Fixture is designed for use in totally or partially edentulous mandibles or maxillae to increase bone height and mass by means of distraction osteogenesis. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the ACE Surgical Alveolar Distractor. This ACE Surgical transitory monofocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones.

Source page: https://510kreport.com/device/K981526
Methodology: https://510kreport.com/methodology