2MM Pediatric Flex Nail
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K022531 FDA 510(k)
- FDA Product Code
- HTY 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 2mm Pediatric Flex Nail is an intramedullary rod classified as a long-bone fracture fixation device. It is designed as a flexible, bendable implant intended for use in pediatric patients to stabilize long-bone fractures. The device operates as a mechanical fastener, providing three-point fixation at the insertion site, fracture site, and beyond the fracture site to enhance structural stability during bone healing. It is supplied in pairs for paired insertion.
This device is used in clinical settings by surgeons to facilitate fracture alignment and healing in pediatric patients. It is intended for single-use and is not sterilized post-manufacture; sterility is maintained through terminal sterilization prior to packaging. The device is regulated under FDA 510(k) clearance (K022531) and falls under the Orthopedic advisory committee classification. No additional regulatory status beyond the stated clearance is implied.
Frequently asked questions
What is the primary purpose of the 2mm Pediatric Flex Nail in clinical practice?
The 2mm Pediatric Flex Nail is designed to stabilize long-bone fractures in pediatric patients by acting as a flexible intramedullary rod. It provides mechanical fixation through three-point stabilization—at the insertion site, fracture site, and beyond the fracture—to help maintain proper alignment and support bone healing during recovery.
How is the 2mm Pediatric Flex Nail supplied, and why is this important for clinical use?
The device is supplied in pairs for paired insertion, which ensures balanced fixation and proper alignment during surgical placement. This paired design is specifically tailored for pediatric long-bone fractures, where precise stabilization is critical for optimal healing outcomes.
Is the 2mm Pediatric Flex Nail intended for reuse, and how is its sterility maintained?
No, the 2mm Pediatric Flex Nail is intended for single-use only. Sterility is maintained through terminal sterilization before packaging, meaning each sterile barrier system is designed to preserve sterility until first use in the operating room, reducing infection risks.
What regulatory pathway does the 2mm Pediatric Flex Nail follow, and what does this mean for clinicians?
The device follows the FDA 510(k) clearance pathway (K022531) under the Orthopedic advisory committee classification, with a special clearance type. This means it has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA standards for safety and effectiveness as an intramedullary fixation solution for pediatric fractures.
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: 2MM PEDIATRIC FLEX NAIL (K022531) — FDA 510(k) | Innolitics, 2MM PEDIATRIC FLEX NAIL (K022531) - FDA 510 (k), 2mm Pediatric Flex Nail 510 (k) FDA Premarket Notification K022531 ..., PDF K022531 2MM PEDIATRIC FLEX NAIL - 510kdatabase.net, 2MM PEDIATRIC FLEX NAIL (K022531) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022531 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K022531 24 fields · synced Sep 20, 2026