# K981259: Osteo 4.0MM Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: May 11, 1998 after 35 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) Synthes 4.0mm Cannulated Screws in the Synthes 4.0mm Screw Set: named in the summary without a submission number
- (no number) ACE Medical 4.0mm Cannulated Screws in the ACE Titanium 3.5/4.0mm Small Fragment System: named in the summary without a submission number
- (no number) Richards 4.0mm Cannulated Screw: 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 4.0mm Cannulated Screw System is indicated for osteochrondritis dissecans, ligament fixation, and long and small bone fracture fixation, which may include the following: Fractures of the olecranon, distal humerus Fractures of the ulna and radius Patellar fractures Distal tibia and pilon fractures Fractures of the tarsals and metatarsals Tarso-metatarsal and metatarso-phalangeal arthrodeses Metatarsal and phalangeal osteotomies Fractures of the posterior wall of the acetabulum and other fractures of the pelvic ring Other small fragment, cancellous bone fractures

Source page: https://510kreport.com/device/K981259
Methodology: https://510kreport.com/methodology