# K082650: Synthes Large External Fixation, MR Conditional

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 18, 2008 after 67 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
23 later devices descend from it; 9 cite it directly.
0 of 24 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
- K111155: Xtrafix External Fixation System (2011), 9 descendants of its own
- K113383: Xtrafix External Fixation System (2012), 8 descendants of its own
- K113770: Orthofix Galaxy Fixation System (2012), 6 descendants of its own
- K122455: Synthes Small External Fixation System, Synthes Large External Fixation System (2013), 3 descendants of its own
- K181528: Austin Miller Large External Fixation System (2019), 2 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
- Apr 10, 2014 · Class II · Z-1833-2014: Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
- Jan 11, 2013 · Class II · Z-0941-2013: The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
- Oct 12, 2012 · Class II · Z-1816-2013: It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, 
- Sep 28, 2012 · Class II · Z-0277-2013: The insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.

## Indications for use
Synthes Large External Fixation is intended for use to 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 - Polytrauma/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

Source page: https://510kreport.com/device/K082650
Methodology: https://510kreport.com/methodology