# K964094: Minifix

- Pathway: 510(k) (Traditional)
- Applicant: Ferguson Medical
- Decided: Nov 27, 1996 after 47 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
Longest line of descent: 1 generation back to K861766 (1986). 2 ancestors in all.
133 later devices descend from it; 4 cite it directly.
0 of 136 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861766: Howmedica Hoffmann Fixation Pin System, Howmedica Corp. (1986) Summary page 1.
- K880282: Lima-Lto. Sem Modular External Stablizer, Lima-Lto, Inc. (1988) Summary page 1.

## Most influential descendants
- K061253: Reflection 3 Acetabular System (2006), 120 descendants of its own
- K070756: Smith and Nephew Reflection 3 Acetabular System (2007), 91 descendants of its own
- K092386: R3 Multi-Hole Shells and 36MM Xlpe Acetabular Liners (2009), 46 descendants of its own
- K100933: Consensus CS2 Plus Acetabular Insert (2010), 35 descendants of its own
- K102399: Consensus Taperset Hip System (2010), 33 descendants of its own

## Indications for use
The MINIFIX is intended for use in the external fixation of fractures and/or reconstruction of small bones, including, but not limited to, metacarpal and metatarsal.

Source page: https://510kreport.com/device/K964094
Methodology: https://510kreport.com/methodology