Osteo 5.0mm Cannulated Screw System
510(k) K983006
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK983006 | Date23 Nov 1998 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HWC
- Device Class
- Class II
- Regulation
- 21 CFR Part 888.3040
- Advisory Committee
- Orthopedic
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Osteo 5.0 mm Cannulated Screw System is a Class 2 orthopedic device designed for internal fixation of bone fractures. It features cannulated screws intended for ligament fixation and stabilization of intermediate-sized bone fragments, including proximal and distal humerus fractures, olecranon process fractures, femoral fractures, and tibial plateau or metaphyseal fractures.
This system is supplied sterile for single-use in orthopedic surgical settings. The cannulated design allows for over-the-wire insertion, facilitating precise placement in complex fracture patterns. Authorized under FDA 510(k) clearance (K983006) via the Traditional pathway, it adheres to regulatory standards for orthopedic hardware (product code HWC) and is intended for use in orthopedic procedures requiring secure internal fixation.
Questions
AI-generated answers, 19 Sep 2026
What types of bone fractures is this cannulated screw system specifically designed to stabilize, and how does the cannulated design help in placement?
The Osteo 5.0 mm Cannulated Screw System is designed for internal fixation of intermediate-sized bone fragments in fractures of the proximal and distal humerus, olecranon process, femur, and tibial plateau or metaphysis. The cannulated design allows for over-the-wire insertion, which enables precise placement—especially useful in complex fracture patterns where accuracy is critical for secure stabilization.
Is this screw system intended for reuse in surgical settings, or is it meant for single-use only?
The Osteo 5.0 mm Cannulated Screw System is supplied sterile and explicitly intended for single-use in orthopedic surgical settings. This ensures patient safety and compliance with sterile procedure protocols, as reuse is not recommended or supported by the manufacturer.
How is this device regulated in the U.S., and what pathway was used for its FDA clearance?
This device is classified as a Class 2 orthopedic implant and was cleared via the Traditional 510(k) pathway under FDA clearance number K983006. The submission was reviewed by the Orthopedic (OR) Advisory Committee and determined to be substantially equivalent to a legally marketed predicate device, adhering to regulatory standards for orthopedic hardware (product code HWC).
What storage conditions should be followed for this screw system to maintain its sterility and performance?
While the exact storage instructions aren’t detailed in the provided data, as a sterile, single-use orthopedic implant, this system should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s enclosed instructions for proper handling and expiration checks to ensure sterility and integrity before use.