# K012634: Reprocessed External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Jun 24, 2002 after 315 days
- Product code: KTW (Appliance, Fixation, Nail/Blade/Plate Combination, Single 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 K870961 (1987). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K870961: Richards External Fixation System, Richards Medical Co., Inc. (1987) Summary page 3.
- K962808: Ilizarov External Fixation System, Smith & Nephew Richards, Inc. (1996) Summary page 3.
- K970713: Compass Universal Hinge, Smith & Nephew, Inc., Orthopaedic Div. (1997) Summary page 3.

## Most influential descendants
- K051554: Alliance Medical Corporation Reprocessed External Fixation Devices (2005), 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/K012634
Methodology: https://510kreport.com/methodology