# K983165: Osteo 4.0MM Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Osteonics Corp.
- Decided: Dec 3, 1998 after 84 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.
42 later devices descend from it; 2 cite it directly.
0 of 43 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) Richards 4.0mm Cannulated Screw: named in the summary without a submission number
- (no number) ACE Medical Titanium 3.5/4.0mm Small Fragment System: named in the summary without a submission number

## Most influential descendants
- K123890: Acumed Cannulated Screw System (2013), 36 descendants of its own
- K190586: Monster® Screw System (2019), 21 descendants of its own
- K200398: AxSOS 3 AF System and AxSOS 3 Ti System (2020), 9 descendants of its own
- K150693: PHIN-FX Cannulated Lag Screw System (2015), 9 descendants of its own
- K222381: PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System (2023), 8 descendants of its own

## 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 Fractures of the fibula, medial malleolus, and os calcis Other small fragment, cancellous bone fractures

Source page: https://510kreport.com/device/K983165
Methodology: https://510kreport.com/methodology