# K983508: Osteo Compression Condyle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 7, 1998 after 61 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
Longest line of descent: 1 generation back to K920037 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971321: Osteo Compression Condyle Screw System, Osteonics Corp. (1997) Summary page 1.
- K920037: Osteo Compression Hip Screw, Osteo AG (1992) Summary page 1.
- (no number) Synthes Dynamic Condylar Screw System: named in the summary without a submission number

## Indications for use
The Osteo Compression Condyle Screw System is a femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws (#£913269) 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. Intercondylar fractures Supracondylar fractures Unicondylar fractures Fractures of the proximal femur: Transverse subtrochanteric fractures Short oblique subtrochanteric fractures Long oblique subtrochanteric fractures The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation and translation of the fracture fragment

Source page: https://510kreport.com/device/K983508
Methodology: https://510kreport.com/methodology