Atlas Fracture Proximal Humeral Nail
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K971816 FDA 510(k)
- FDA Product Code
- HSB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3020 FDA 510(k)
- Regulation Number
- 888.3020 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Atlas Fracture Proximal Humeral Nail is a modular intramedullary fixation device designed for the stabilization of proximal humerus fractures. It consists of a proximal solid cylinder with multiple screw holes for fragment reconstruction and suture holes for soft tissue reattachment, paired with a distal tapered, fluted intramedullary stem to provide rotational stability. This system is classified as a Rod, Fixation, Intramedullary (product code HSB) and is intended for orthopedic use in fracture fixation procedures.
The device is supplied as a reusable surgical implant and is intended for use in orthopedic operating rooms. It is not sterile at the time of shipment and must be sterilized prior to use, adhering to standard medical device sterilization protocols. The nail system is regulated under FDA 510(k) clearance (K971816) and falls under Class II – Special Controls. No specific MRI safety information is provided in the available data.
Frequently asked questions
What is the Atlas Fracture Proximal Humeral Nail used for?
The Atlas Fracture Proximal Humeral Nail is designed specifically for the stabilization of proximal humerus fractures. Its modular design includes a proximal solid cylinder with multiple screw holes to reconstruct fracture fragments and suture holes for soft tissue reattachment. The paired distal tapered, fluted intramedullary stem provides rotational stability, ensuring proper alignment and fixation during the healing process.
Is the Atlas Proximal Humeral Nail sterile upon receipt?
No, the Atlas Proximal Humeral Nail is not sterile at the time of shipment. It is classified as a reusable surgical implant and must be sterilized according to standard medical device sterilization protocols before use in an orthopedic operating room.
How is the nail system supplied, and what are its key components?
The nail system is supplied as a reusable implant intended for orthopedic fracture fixation. It consists of two primary components: a proximal solid cylinder with multiple screw holes for fragment reconstruction and suture holes for soft tissue reattachment, and a distal tapered, fluted intramedullary stem. This modular design allows for tailored fixation based on the specific fracture pattern.
Can this device be reused, and what are the regulatory considerations?
Yes, the Atlas Proximal Humeral Nail is designed for reuse. It is regulated under the FDA’s 510(k) clearance process (K971816) and falls under Class II – Special Controls. The device is classified under product code HSB (Rod, Fixation, Intramedullary) and is intended for orthopedic use in fracture fixation procedures. Reuse must comply with sterilization protocols to ensure safety and efficacy.
Are there any special considerations for storage or handling?
While specific storage instructions are not detailed in the provided data, reusable medical devices like the Atlas Proximal Humeral Nail should be stored in a clean, dry environment to prevent contamination. Prior to use, the device must undergo sterilization as per established medical protocols to ensure it remains safe for surgical implantation. Always follow manufacturer guidelines for handling and storage.
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: ATLAS FRACTURE PROXIMAL HUMERAL NAIL - Innolitics, K971816 - ATLAS FRACTURE PROXIMAL HUMERAL NAIL | FDA 510 (k), PDF K971816 - Atlas Fracture Proximal Humeral Nail
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K971816 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K971816 24 fields · synced Oct 1, 2026