# K043039: Synthes (Usa) External Fixation Component Line Extension - MR Safe

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 18, 2005 after 75 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
No predicates in its family tree.
4 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) Synthes Reprocessed External Fixation Devices: named in the summary without a submission number
- (no number) Hoffmann II External Fixation System (Stryker): named in the summary without a submission number
- (no number) FBI XFLX Vision Fixation System: 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

## Indications for use
Synthes External Fixation Devices - MR Safe are 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 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/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.

Source page: https://510kreport.com/device/K043039
Methodology: https://510kreport.com/methodology