# K051957: Reprocessed External Fixation Device

- Pathway: 510(k) (Traditional)
- Applicant: Sterilemed, Inc.
- Decided: Sep 21, 2005 after 68 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031428 (2003). 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)
- K033158: Synthes Reprocessed External Fixation Devices, Synthes (Usa) (2003) Summary page 1.
- K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe, Synthes (Usa) (2003) Summary page 1.
- K040258: Synthes Medium External Fixation System-MR Safe, Synthes (Usa) (2004) Summary page 1.

## Recalls of this device
- Aug 8, 2008 · Not classified · Z-0556-2009: SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility exists that some of th

## Indications for use
The Reprocessed External Fixation Device is intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. LARGE Provide treatment for long bone and pelvic fractures that require external fixation Specifically, the components are used for: * Stabilization of soft tissues and fractures * Polytrauma/multiple orthopedic trauma * Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures * Arthrodeses and osteotomies with soft tissue problems; failures of total joints * Neutralization of fractures stabilized with limited internal fixation * Non-unions/septic non-unions * Intra-operative reductions/stabilization tool to assist with indirect reduction * Unilateral rectilinear bone segment transport or leg lengthening MEDIUM Indicated for construction of an external fixation frame for the treatment of pediatric and adult fractures. SMALL Stabilizes and provides treatment for fractures of the small bones, such as the hand, wrist, forearm, foot and ankle. Specifically, the components can be used for: * Preliminary fixation before ORIF * Unstable fractures of the distal radius (both intra and extra-articular) * Open and/or comminuted bilateral fractures * Fractures in combination with extensive soft tissue injury, bone loss, and vascular and/or neural involvement * Fracture dislocations * Failed closed reduction with casting resulting in secondary deformity (radial shortening and angulations) * Pediatric open fractures with bone loss and osteotomy MINI Stabilizes and provides treatment for fractures of the hand and foot. Specifically, the components can be used for: * Comminuted fractures of phalanges and metacarpals * Displaced intra-articular fractures * Segmental bone loss * Open fractures that do not allow stable internal fixation * Fractures with associated complex soft tissue injuries * Tumor resections

Source page: https://510kreport.com/device/K051957
Methodology: https://510kreport.com/methodology