# K032058: Modification to Reprocessed Synthes External Fixation Devices

- Pathway: 510(k) (Special)
- Applicant: Alliance Medical Corp.
- Decided: Jul 30, 2003 after 28 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000682 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012623: Reprocessed External Fixation Device, Alliance Medical Corp. (2002)

## Indications for use
Reprocessed external fixation devices are indicated for use in patients requiring external skeletal fixation and treatment of fractures, osteotomy, arthrodesis, correction of deformities, fracture revision, bone reconstruction procedures, limb lengthening, correction of bony or soft tissue deformities and segmental bony or soft tissue defects.

Source page: https://510kreport.com/device/K032058
Methodology: https://510kreport.com/methodology