# K971321: Osteo Compression Condyle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jul 9, 1997 after 90 days
- Product code: HRS (Plate, Fixation, Bone)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Synthes Dynamic Condylar Screw System: named in the summary without a submission number

## Most influential descendants
- K983508: Osteo Compression Condyle Screw System (1998), 0 descendants of its own

## Indications for use
The Osteo Compression Condyle Screw System is a distal 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 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 Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures Supracondylar fractures Unicondylar fractures

Source page: https://510kreport.com/device/K971321
Methodology: https://510kreport.com/methodology