# K012623: Reprocessed External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Jun 24, 2002 after 315 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: 1 generation back to K000682 (2000). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000682: Synthes Large Fragment Dynamic Compression Locking (DCL) System, Synthes (Usa) (2000)
- K010344: Adjustable Large Fixator System, Synthes (Usa) (2001)
- (no number) Synthes TraumaFixTM External Fixator: named in the summary without a submission number
- (no number) Synthes (U.S.A.) Mini External Fixator: named in the summary without a submission number
- (no number) Synthes Titanium External Fixator Clamps: named in the summary without a submission number
- (no number) Synthes Combination Clamp and Dynamization Clip: named in the summary without a submission number
- (no number) Synthes Simple Small External Fixator: named in the summary without a submission number

## Most influential descendants
- K032058: Modification to Reprocessed Synthes External Fixation Devices (2003), 0 descendants of its own

## 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/K012623
Methodology: https://510kreport.com/methodology