# K021342: Normed BI-Directional/Multidirectional Jaw Distractor

- Pathway: 510(k) (Traditional)
- Applicant: Osteomedics, Inc.
- Decided: Aug 1, 2002 after 94 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
Longest line of descent: 1 generation back to K952847 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952847: Normed Bidirectrional/Multidirectional Jaw Distractor, Ace Surgical Supply Co., Inc. (1996) Summary page 1.

## Indications for use
The intended use of the Normed Bi-Directional/ Multi-Directional Jaw Distractor is identical to the description in the 510(k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.

Source page: https://510kreport.com/device/K021342
Methodology: https://510kreport.com/methodology