Identifiers
- 510(k) Number
- K171510 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Footmotion Plating System is a compressive straight plate device designed for the fixation of fractures, osteotomies, and arthrodesis in small bones and bone fragments, primarily within the foot. It falls under the category of orthopedic implants, providing mechanical stability to bone structures through rigid plating. The system includes a range of plates with oblong holes to facilitate controlled compression, enhancing construct stability during healing. Its design supports both primary and revision surgeries, ensuring adaptability to complex clinical scenarios.
This system is supplied as a sterile, single-use kit containing six implants with hole configurations ranging from two to seven. It is intended for use in adult foot and ankle procedures under sterile conditions, typically in operating rooms or specialized orthopedic settings. The plates are non-MRI-compatible and must be handled according to manufacturer guidelines for storage and preparation. Authorized for use in the U.S. under FDA 510(k) clearance (K171510) and classified as EC Class IIb, the device adheres to regulatory standards for orthopedic fixation hardware.
Frequently asked questions
What is the Footmotion Plating System used for?
The Footmotion Plating System is designed for fixation of fractures, osteotomies, and arthrodesis in small bones and bone fragments within the foot. It provides mechanical stability through rigid plating and supports both primary and revision surgeries.
How is the Footmotion Plating System supplied?
The system is supplied as a sterile, single-use kit containing six implants with hole configurations ranging from two to seven. It is intended for use in adult foot and ankle procedures under sterile conditions in operating rooms or specialized orthopedic settings.
What are the regulatory approvals for the Footmotion Plating System?
The device is authorized for use in the U.S. under FDA 510(k) clearance (K171510) and is classified as EC Class IIb. It adheres to regulatory standards for orthopedic fixation hardware, though it is non-MRI-compatible.
Can the Footmotion Plating System be reused?
No, the Footmotion Plating System is supplied as a single-use device and should not be reused. Each kit contains sterile implants that must be handled according to manufacturer guidelines for storage and preparation to maintain sterility and device integrity.
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: Footmotion Plating System - Newclip Technics, PDF FOOTMOTION PLATING SYSTEM - Newclip Technics, PDF FOOTMOTION PLATING SYSTEM - newcliptechnics.us, Footmotion Plating System - Newclip Technics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K171510 | Class II | Active |
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Manufacturer
- Manufacturer
- Newclip Technics
Sources (1)
- FDA 510(k) K171510 24 fields · synced Oct 1, 2026