# K961433: Ebi X Fix Dynafix System/Ebi DFS Distal Radius Fixator SC Bone Screws

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Biology, Inc.
- Decided: Jun 28, 1996 after 74 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.
8 later devices descend from it; 4 cite it directly.
0 of 9 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 X FIX™ DynaFix™ System and DFS™ Distal Radius Fixator Bone Screws: named in the summary without a submission number
- (no number) Vitaphore SilverFoam Wound Dressing: named in the summary without a submission number
- (no number) Genetic Laboratories E-Z DERM™ Temporary Skin Substitute with Silver: named in the summary without a submission number
- (no number) Arrow Antimicrobial Multi-Lumen Central Venous Catheter: named in the summary without a submission number
- (no number) Vitaphore Pin Protection Device: named in the summary without a submission number

## Most influential descendants
- K081244: Lower Extremity External Fixation - Expanded Indications (2008), 2 descendants of its own
- K012193: Amc Antimicrobial Pin/Wire Sleeve (2002), 2 descendants of its own
- K122210: Newfix External Fixation System (2013), 0 descendants of its own
- K102843: Mac Male Adapter (2011), 0 descendants of its own
- K060288: Retro Silver and Xpresso Silver Chronic Hemodialysis Catheters (2006), 0 descendants of its own

## Indications for use
The EBI X FIX DynaFix System is intended for the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The EBI DFS™ Distal Radius Fixator is intended for use in upper extremity applications for the reduction, alignment and stabilization of intra-articular and extra-articular fractures, corrective osteotomies, and soft tissue deformities.

Source page: https://510kreport.com/device/K961433
Methodology: https://510kreport.com/methodology