# K961350: Synthes Mini External Fixator

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jun 28, 1996 after 84 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.
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) Howmedica Mini Hoffmann External 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
- K101338: Newfix External Fixation System (2011), 0 descendants of its own

## Indications for use
The Synthes Mini External Fixator stabilizes and provides treatment for fractures of the hand and foot.

Source page: https://510kreport.com/device/K961350
Methodology: https://510kreport.com/methodology