# K954555: Versa-FX Femoral Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Jan 26, 1996 after 116 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
76 later devices descend from it; 3 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983814: Gotfried Percutaneous Compression Plating System (1999), 71 descendants of its own
- K080434: Intertan CHS Locking Plate System Prox Fem Plates/Screw (2008), 35 descendants of its own
- K090656: Intertan CHS Limited Collapse Set Screw (2009), 34 descendants of its own
- K123055: Smith & Nephew, Inc Screw and Plate System Instrumentation (2013), 33 descendants of its own
- K140814: Evos Mini-Fragment Plating System (2014), 32 descendants of its own

## Recalls of this device
- Oct 11, 2013 · Class II · Z-1005-2014: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packag

Source page: https://510kreport.com/device/K954555
Methodology: https://510kreport.com/methodology