# K971654: Osteo Compression Hip Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jul 9, 1997 after 64 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- 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) Howmedica Omega Plus Compression Hip Screw System: named in the summary without a submission number

## Indications for use
The Osteo Compression Hip Screw System is a proximal femoral fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. Osteo Cortical Bone Screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Hip Screw System is indicated for the following proximal fractures of the femur: . Intracapsular fractures of the femoral neck. . Intertrochanteric fractures of the femur.

Source page: https://510kreport.com/device/K971654
Methodology: https://510kreport.com/methodology