# K962846: EZ-Fix Compression Hip/Supracondylar Screw (CHS) System

- Pathway: 510(k) (Traditional)
- Applicant: Biodynamic Technologies, Inc.
- Decided: Oct 23, 1996 after 93 days
- Product code: LXT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite)
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Alphatec Modular Hip Screw System: named in the summary without a submission number
- (no number) Ace Captured Hip Screw System: named in the summary without a submission number
- (no number) Richards Classic and AMBI Compression Hip Screw Systems: named in the summary without a submission number
- (no number) Howmedica ALTA Modular Hip Screw System: named in the summary without a submission number
- (no number) Zimmer Free-Lock Compression Hip Fixation System: named in the summary without a submission number
- (no number) Zimmer Versa-Fx Femoral Fixation System: named in the summary without a submission number

## Indications for use
to stabilize intracapsular fractures of the neck of the femur; class 1, 11, N, and IV trochanteric and subtrochanteric fractures with appropriate additional postoperative precautions against weight-bearing and against more than sedentary activity; supracondylar fractures and distal femoral fractures using a 95° barrel angle

Source page: https://510kreport.com/device/K962846
Methodology: https://510kreport.com/methodology