# K964880: Vari-Angle Hip Screw (VHS) System

- Pathway: 510(k) (Traditional)
- Applicant: Walter Abendschein, M.D.
- Decided: Oct 16, 1997 after 315 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.
34 later devices descend from it; 2 cite it directly.
0 of 35 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) Free-Lock Compression Hip Fixation System (Zimmer): named in the summary without a submission number
- (no number) AMBI Hip Screw System (Richards): named in the summary without a submission number
- (no number) Dynamic Hip Screw (DHS) (Synthes): named in the summary without a submission number
- (no number) Versa-Fx Femoral Fixation System (Zimmer): named in the summary without a submission number
- (no number) Ace Captured Hip Screw System (Ace Medical): named in the summary without a submission number
- (no number) Combination NoLok/Keyed Compression Hip Screw System (DePuy): named in the summary without a submission number
- (no number) Medoff Sliding Plate (Wright Medical Technology): named in the summary without a submission number

## Most influential descendants
- K031401: Fixion Dynamic Hip Screw System (Fixion DHS) (2003), 32 descendants of its own
- K091425: Quantum M Composite Nailing System (2010), 31 descendants of its own
- K100497: Quantum IM Composite Nailing System (Quantum Nailing System) (2010), 29 descendants of its own
- K102369: Piccolo Composite Nailing System (2011), 16 descendants of its own
- K111056: Piccolo Composite Nailing System (2011), 15 descendants of its own

## Recalls of this device
- Apr 1, 2016 · Class II · Z-1825-2016: Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non

## Indications for use
The Vari-Angle Hip Screw is indicated for use in the treatment of displaced sub-capital fractures, sub-trochanteric and inter-trochanteric fractures, arthrodesis, moderately displaced femoral capital epiphysis, varus or valgus osteotomies of the hip and medial displacement osteotomies.

Source page: https://510kreport.com/device/K964880
Methodology: https://510kreport.com/methodology