# K960014: Practifix External Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Orthopaedic Innovations, Inc.
- Decided: Mar 18, 1996 after 76 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Hex-Fix External Fixation by Smith and Nephew Richards: named in the summary without a submission number
- (no number) Day External Fixation by DePuy: named in the summary without a submission number
- (no number) AP/ASIF External Fixation System by Synthes: named in the summary without a submission number

## Most influential descendants
- K983881: Cobra External Fixator (1998), 1 descendant of its own
- K012078: Radiofix (2001), 0 descendants of its own

## Indications for use
Indications for use include: fracture fixation(open and closed); pseudarthrosis or long bones (both congenital and acquired); limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformities; correction of osteotomies; and correction of bony or soft tissue defects.

Source page: https://510kreport.com/device/K960014
Methodology: https://510kreport.com/methodology