# K990140: Normed Bone Transport

- Pathway: 510(k) (Traditional)
- Applicant: Ace Surgical Supply Co., Inc.
- Decided: Mar 25, 1999 after 65 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K021341: Normed Bone Transport Distraction Device (2002), 0 descendants of its own

## Indications for use
The ACE/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 ACE/Normed Transport Distraction Device. This ACE/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 . - Severe open mandibular fractures + Facial deformity corrections

Source page: https://510kreport.com/device/K990140
Methodology: https://510kreport.com/methodology