OsteoCentric Cannulated Fasteners and Nuts
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K242691 FDA 510(k)
- FDA Product Code
- HWC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3040 FDA 510(k)
- Regulation Number
- 888.3040 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The OsteoCentric Cannulated Fasteners and Nuts are orthopedic fixation devices designed for reduction and stabilization of fractures, interosseous distances, and bone reconstruction. These cannulated fasteners and corresponding nuts provide mechanical support in procedures such as osteotomy, arthrodesis, and fracture fixation, ensuring secure alignment and healing of bone structures. Manufactured from stainless steel per ASTM F138, they are engineered to accommodate varying lengths and diameters for procedural adaptability.
Supplied non-sterile, these devices are intended for use in surgical settings where aseptic techniques are applied. They are classified under FDA product code HWC and received Special 510(k) clearance (K242691) on October 9, 2024, under the Orthopedic Advisory Committee. Sizes include 7.0mm and 8.0mm cannulated nuts, with fasteners available in multiple lengths and diameters to match clinical requirements.
Frequently asked questions
What are the OsteoCentric Cannulated Fasteners and Nuts used for?
These orthopedic fixation devices are designed for reduction and stabilization of fractures, interosseous distances, and bone reconstruction. They provide mechanical support in procedures such as osteotomy, arthrodesis, and fracture fixation to ensure secure alignment and healing of bone structures.
How are the OsteoCentric Cannulated Fasteners and Nuts supplied?
The devices are supplied non-sterile and are intended for use in surgical settings where aseptic techniques are applied. They are manufactured from stainless steel per ASTM F138 and are available in various sizes including 7.0mm and 8.0mm cannulated nuts, with fasteners in multiple lengths and diameters to match clinical requirements.
What is the regulatory status of the OsteoCentric Cannulated Fasteners and Nuts?
These devices received Special 510(k) clearance (K242691) on October 9, 2024, under the Orthopedic Advisory Committee. They are classified under FDA product code HWC and are considered substantially equivalent to predicate devices.
Are the OsteoCentric Cannulated Fasteners and Nuts single-use or reusable?
The device description does not specify whether these fasteners and nuts are single-use or reusable. As they are supplied non-sterile and intended for use in surgical settings with aseptic techniques, the reuse policy would depend on the healthcare facility's protocols and sterilization capabilities.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cannulated Fastener System | Osteocentric, OsteoCentric Technologies Cannulated Fasteners and Nuts (K242691) — FDA ..., OsteoCentric Technologies Cannulated Fasteners and Nuts
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242691 | Class II | Active |
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Manufacturer
- Manufacturer
- OsteoCentric Technologies
Sources (1)
- FDA 510(k) K242691 24 fields · synced Oct 1, 2026