# K050631: Synthes (Usa) Small Adjustable Clamp-MR Safe Line Extension

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Apr 11, 2005 after 31 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: 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 4.0 mm Adjustable Clamp for Distal Radius Fixator - MR Safe: named in the summary without a submission number
- (no number) Synthes Small Combination Clamp - MR Safe: 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 Small Adjustable Clamps - MR Safe Line Extension are intended for fractures of the distal radius, fractures and dislocations of the hand, wrist, mandible and foot (including open and/or bilateral fractures); fractures in combination with extensive soft tissue injury, bone loss, vascular and/or neural involvement; and failed closed reduction and casting resulting in secondary deformity of the distal radius.

Source page: https://510kreport.com/device/K050631
Methodology: https://510kreport.com/methodology