Titanium Intramedullary Nails-Various Styles
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K982953 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 Titanium Intramedullary Nails – Various Styles are orthopedic fixation devices designed for internal stabilization of long bone fractures. These nails are inserted into the medullary cavity of bones such as the femur or tibia to maintain alignment and promote proper healing during the fracture repair process. Constructed from titanium alloy, they offer a balance of strength, biocompatibility, and resistance to corrosion, making them suitable for long-term implantation. The device is categorized under Rod, Fixation, Intramedullary and Accessories (Product Code: HSB) and is intended for surgical use in orthopedic procedures.
These nails are supplied sterile and intended for single-use in controlled surgical environments. They are available in various styles to accommodate different anatomical requirements and fracture patterns, ensuring versatility in clinical applications. The device complies with FDA 510(k) clearance (K982953) under Traditional review, classified as a Class II medical device with Special Controls. Storage and handling must adhere to sterile medical device protocols to maintain integrity prior to use.
Frequently asked questions
What are the Titanium Intramedullary Nails – Various Styles used for?
These nails are designed for internal stabilization of long bone fractures, such as those in the femur or tibia. By inserting them into the medullary cavity, they maintain proper bone alignment during the healing process, reducing the risk of displacement and promoting effective fracture repair. The titanium alloy construction ensures durability and biocompatibility for long-term implantation.
Are the Titanium Intramedullary Nails supplied sterile and for single-use?
Yes, the nails are supplied sterile and intended exclusively for single-use in controlled surgical environments. This ensures patient safety by preventing contamination and cross-infection, while adhering to best practices for orthopedic fixation devices.
What materials are the nails made from, and why?
The nails are constructed from titanium alloy, which provides a balance of strength, lightweight durability, and resistance to corrosion. Titanium is also highly biocompatible, reducing the risk of adverse reactions in the body during long-term implantation.
How are the nails categorized and regulated?
These nails fall under the Product Code HSB (Rod, Fixation, Intramedullary and Accessories) and are classified as a Class II medical device with Special Controls. They hold FDA 510(k) clearance (K982953) under Traditional review, meaning they were deemed substantially equivalent to a legally marketed predicate device for their intended use.
What storage and handling precautions must be followed?
The nails must be stored and handled according to sterile medical device protocols to preserve their integrity before use. This includes maintaining proper packaging, avoiding contamination, and adhering to manufacturer guidelines for shelf life and environmental conditions to ensure sterility and functionality.
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: TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES (K982953) — FDA 510 (k ..., K982953 FDA 510(k) - TITANIUM INTRAMEDULLARY NAILS-VARIOUS S..., Titanium Intramedullary Nails-various Styles - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K982953 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K982953 24 fields · synced Oct 1, 2026