# K150818: Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 1, 2015 after 35 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K791619 (1979). 3 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K840954: Dynamic Condylar Screw or D.C.S., Synthes (Usa) (1984) Summary page 6.
- K954555: Versa-FX Femoral Fixation System, Zimmer, Inc. (1996) Summary page 6.
- K791619: Dynamic Hip Screw, Synthes (Usa) (1979) Summary page 6.

## Most influential descendants
- K210247: OsteoCentric Integrated Hip Fastener System (2021), 1 descendant of its own
- K230764: OsteoCentric Integrated Hip Fastener System (2023), 0 descendants of its own

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0326-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- May 4, 2016 · Class II · Z-1682-2016: A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.
- Jan 11, 2016 · Class II · Z-1129-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1139-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1118-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
- Jan 11, 2016 · Class II · Z-1163-2016: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

## Indications for use
The Versa-Fx Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures. Supracondylar: The Versa-Fx II Femoral Fixation System may be used for the internal fixation of supracondylar fractures with displaced intra-articular fragments, with vertical intra-articular extension, and in the patient with multiple lower extremity fractures. Proximal Femur: The Versa-Fx II Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture). The Free-Lock Femoral Fixation System may be used for internal fixation of hip fractures with application to intracapsular and intertrochanteric fractures, osteotomies, arthrodeses, and subtrochanteric fractures with extension into the greater trochanter and the piriformis fossa (Winquist Type III comminuted fracture).

Source page: https://510kreport.com/device/K150818
Methodology: https://510kreport.com/methodology