# K030390: Synthes Large Combination Clamp and Dynamization Clip - MR Safe

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 1, 2003 after 55 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (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 Combination Clamp and Dynamization Clip: 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
- K122208: External Fixator System (2012), 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
- 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.

## Indications for use
Synthes Combination Clamp and Dynamization Clip - MR Safe are generally intended to be used in the construction of an external fixation frame to treat long bone and pelvic fractures. Specifically, the Synthes Combination Clamp with Dynamization Clip is intended for: Stabilization of soft tissue injuries and open or closed fractures; Polytrauma; Vertically stable pelvic fractures as a treatment adjunct for vertically unstable pelvic fractures; Arthrodesis and osteotomies with soft tissue problems; Failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions; Intraoperative reduction/stabilization tool to assist with indirect reduction; Unilateral rectilinear bone segment transport or leg lengthening.

Source page: https://510kreport.com/device/K030390
Methodology: https://510kreport.com/methodology