# K971800: Osteo Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Jul 30, 1997 after 76 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) Smith & Nephew 6.5mm Universal Cannulated Screw System: named in the summary without a submission number
- (no number) Smith & Nephew 8.0mm Cannulated Screw System: named in the summary without a submission number
- (no number) Synthes 7.3mm Cannulated Screw System: named in the summary without a submission number

## Indications for use
The indications for the use of these cannulated screws, in keeping with those of other legally marketed cannulated screws, are as follows. The Osteo Cannulated Screw System is indicated for the following: Intracapsular fractures of the femoral neck Intertrochanteric fractures of the femur Tibial plateau fractures Fractures of the dorsal pelvic ring Pelvic sacroiliac joint disruptions Ankle arthrodesis

Source page: https://510kreport.com/device/K971800
Methodology: https://510kreport.com/methodology