# K011603: VHS Pediatric Hip Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Walter Abendschein, M.D.
- Decided: Aug 15, 2001 after 83 days
- Product code: KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: 2 (0 Class I)
- 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) Pediatric Compression Hip Screw System (Smith & Nephew Richards): named in the summary without a submission number
- (no number) Trauma Internal Fixation System (Smith & Nephew Inc.): named in the summary without a submission number
- (no number) VHS Vari-Angle Compression Hip Screw System (Biomet): named in the summary without a submission number
- (no number) Pediatric Osteotomy System (Howmedica): named in the summary without a submission number

## Recalls of this device
- Sep 6, 2006 · Not classified · Z-0180-2007: VHS Plate and lag screw components did not assemble correctly intraoperatively.
- Sep 6, 2006 · Not classified · Z-0181-2007: VHS Plate and lag screw components did not assemble correctly intraoperatively.

## Indications for use
The VHS™ Pediatric Hip Screw System is used for fracture fixation in the proximal and distal regions of the femur. In particular, indications for use in pediatric patients are as follows : 1. Congenital coxa vara. Congenital dislocation of the hip 3. Subluxation or dislocation secondary to neurologic disorders, such as cerebral palsy, myelomenigocele, poliomyelitis, etc. Usually valgus-anteversion deformities. 4. Coxa plana ( Legg-Calve-Perthes disease )

Source page: https://510kreport.com/device/K011603
Methodology: https://510kreport.com/methodology