# K031428: Synthes (Usa) Large External Fixation Clamps-MR Safe

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Aug 8, 2003 after 94 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
19 later devices descend from it; 6 cite it directly.
0 of 20 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 Universal Clamp (four and six position), and Rod Attachment: named in the summary without a submission number
- (no number) Synthes Tube-to-Tube Clamp: named in the summary without a submission number
- (no number) Synthes Adjustable Clamp: named in the summary without a submission number

## Most influential descendants
- K091258: Extrafix External Fixation System (2009), 11 descendants of its own
- K111155: Xtrafix External Fixation System (2011), 9 descendants of its own
- K113383: Xtrafix External Fixation System (2012), 8 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

## Indications for use
Synthes Large External Fixation Clamps - MR Safe are indicated for use in construction of an external fixation frame for treatment of long bone and pelvic fractures that require external fixation. Specifically, the Synthes MR Safe Large External Fixation Clamps and their accessories are intended for: Stabilization of open or closed fractures with soft tissue injuries; Polytrauma; Vertically stable pelvic fractures or as a treatment adjunct for vertically unstable pelvic fractures; Arthrodesis and osteotomies with soft tissue problems; Failures of totai joints; Neutralization of fractures stabilized with limited internal fixation; Non-uniondseptic non-unions; Intraoperative reductiodstabilization tool to assist with indirect reduction; Unilateral rectilinear bone segment transport or leg lengthening

Source page: https://510kreport.com/device/K031428
Methodology: https://510kreport.com/methodology