# K021341: Normed Bone Transport Distraction Device

- 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 K990140 (1999). 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)
- K990140: Normed Bone Transport, Ace Surgical Supply Co., Inc. (1999) Summary page 1.

## Indications for use
The intended use of the Normed Transport Distraction Device is described and is identical to the 510(k) number K990140 in which, the Normed Transport Distraction Device 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 Normed Transport Distraction Device. This Normed transitory monofocal or bifocal distraction device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are as follows: Tumor Resections Severe trauma which make continuous bone segments no longer possible Bone grafting defects Sever open mandibular fractures Facial deformity corrections

Source page: https://510kreport.com/device/K021341
Methodology: https://510kreport.com/methodology