Identifiers
- 510(k) Number
- K142388 FDA 510(k)
- FDA Product Code
- JWH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3560 FDA 510(k)
- Regulation Number
- 888.3560 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Neo Total Knee System is an orthopedic device used for total knee replacement procedures. It is designed to provide a solution for patients requiring knee arthroplasty, helping to restore mobility and function to the knee joint.
The system is supplied as a medical device and is subject to regulatory oversight. It has received FDA 510(k) clearance with the product code JWH and is manufactured by New Era Orthopedics, LLC. The device is available in various sizes to accommodate different patient anatomies.
Frequently asked questions
What is the Neo Total Knee System used for?
The Neo Total Knee System is an orthopedic device designed for total knee replacement procedures to restore mobility and function to the knee joint in patients requiring knee arthroplasty.
What sizes are available for the Neo Total Knee System?
The Neo Total Knee System is available in various sizes to accommodate different patient anatomies, ensuring proper fit and functionality for a range of patients.
What is the regulatory status of the Neo Total Knee System?
The Neo Total Knee System has received FDA 510(k) clearance with product code JWH, indicating it is substantially equivalent to predicate devices for total knee replacement.
Who manufactures the Neo Total Knee System?
The Neo Total Knee System is manufactured by New Era Orthopedics, LLC, located in Hummelstown, Pennsylvania, and is subject to regulatory oversight as a medical device.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142388 | Class II | Active |
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Manufacturer
- Manufacturer
- New Era Orthopedics Llc
- FDA Applicant
- New Era Orthopedics, LLC
Sources (1)
- FDA 510(k) K142388 24 fields · synced Oct 6, 2026