# K033158: Synthes Reprocessed External Fixation Devices

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 5, 2003 after 36 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
No predicates in its family tree.
5 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes External Fixation Devices: named in the summary without a submission number

## Most influential descendants
- K122455: Synthes Small External Fixation System, Synthes Large External Fixation System (2013), 3 descendants of its own
- K141912: Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon (2014), 1 descendant of its own
- K232897: Arthrex Small External Fixation System (2023), 0 descendants of its own
- K171911: Medline ReNewal Reprocessed Synthes External Fixation Systems (2017), 0 descendants of its own
- K051957: Reprocessed External Fixation Device (2005), 0 descendants of its own

## Recalls of this device
- Jul 29, 2015 · Class II · Z-2451-2015: Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System p

## Indications for use
Synthes External Fixation Devices are intended for use in the construction of an external fixation frame for treatment of various fracture types that require external fixation. LAFtGE/HYBRID Provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures Poyltrauma/multiple orthopedic trauma Vertically stable pelvic fractures, or as a 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/stabilizationtool to assist with indirect reduction Unilateral rectilinear bone segment transport or leg lengthening Hybrid components are designed for fixation of complex proximal and distal tibia fractures, particularly those involving the joint, when soft tissue injuries preclude open reduction and internal fixation, or the fracture pattern does not allow placement of Schanz screws for construction of a standard external fixation frame 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 osteotomies 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 Segmentalboneloss Open fractures that do not allow stable internal fixation Fractures with associated complex soft tissue injuries Tumor resections

Source page: https://510kreport.com/device/K033158
Methodology: https://510kreport.com/methodology