# K983006: Osteo 5.0MM Cannulated Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Stryker Osteonics
- Decided: Nov 23, 1998 after 87 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.
50 later devices descend from it; 2 cite it directly.
0 of 51 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 Titanium 4.5mm Cannulated Screw: named in the summary without a submission number
- (no number) 4.5mm & 5.0mm cannulated screws in the ACE Medical Titanium Cannulated Screw and Reconstruction Plate System: named in the summary without a submission number

## Most influential descendants
- K083912: Treu; Bone Screws, Schanz Screws, Kirschner Wires, Steinmann Pins, Larsen Pins (2009), 48 descendants of its own
- K112727: Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless Compression Screws, Medical (2012), 9 descendants of its own
- K110895: Ortho Solutions Trauma Implants for Osteosynthesis (2011), 8 descendants of its own
- K102845: Mahe Fixation Plate and Screw System (2011), 8 descendants of its own
- K132820: Vilex Ultima External Fixation System with HA Coated Pins and Wires (2014), 5 descendants of its own

## Indications for use
The Osteo 5.0mm Cannulated Screw Systems are indicated for ligament fixation and long and small bone fracture fixation, which may include the following: For 25.0mm Cannulated Screws: . Fixation of intermediate-sized fragments in fractures such as: - proximal and distal humerus fractures - fractures of the olecranon process - femoral fractures - tibial plateau and metaphyseal fractures of the proximal and distal tibia - medial and lateral malleolar and pilon fractures - os calcis, talar, and patellar fractures . Ligament fixation of the proximal humerus . Fractures of the pelvis and acetabulum . Arthrodesis of the tarsals

Source page: https://510kreport.com/device/K983006
Methodology: https://510kreport.com/methodology