# K052918: Reprocessed External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical Corp.
- Decided: Jan 27, 2006 after 102 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 K875022 (1988). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021933: Tempfix External Fixation System, DePuy Orthopaedics, Inc. (2002) Summary page 1.
- K875022: Ace/Fisher Percutaneous Transfixing Pins, Buckman Co., Inc. (1988) Summary page 1.
- K875012: Ace/Fischer Percutaneous Half Pins, Buckman Co., Inc. (1988) Summary page 1.
- K910986: Hoffmann Dynamic Wrist Fixator, Howmedica Corp. (1992) Summary page 1.

## 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/K052918
Methodology: https://510kreport.com/methodology