# K963618: Synthes Simple Small External Fixator (Ssef)

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Nov 12, 1996 after 63 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.
10 later devices descend from it; 3 cite it directly.
0 of 11 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) EBI’s Orthofix Penning Dynamic Wrist Fixator: named in the summary without a submission number

## Most influential descendants
- K984498: Synthes (Usa) Articulating Distal Radius (Adrf) System (1999), 5 descendants of its own
- K012294: Wristore Fixator (2002), 3 descendants of its own
- K993649: Ebi Xfix DFS Wristfix System (1999), 3 descendants of its own
- K042761: Wristore Distal Radius Fracture Fixator, 4600 Series (2004), 1 descendant of its own
- K012062: PF2 (2001), 1 descendant of its own

## Indications for use
The Synthes SSEF stabilizes fractures of the distal radius.

Source page: https://510kreport.com/device/K963618
Methodology: https://510kreport.com/methodology