Identifiers
- 510(k) Number
- K201611 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 Apex Knee System is a semi-constrained, cemented, patellofemorotibial knee prosthesis. It is designed as a total knee implant system to function as a replacement for the knee joint.
This device is classified as a Class II medical device under product code JWH. It has received FDA 510(k) clearance, identified by k-number K201611. The system is composed of polymer and metal materials.
Frequently asked questions
What is the intended use of the Apex Knee System?
The Apex Knee System is a semi-constrained, cemented, patellofemorotibial knee prosthesis designed to function as a total knee implant system for the replacement of the knee joint.
What materials are used in the construction of this knee system?
The Apex Knee System is manufactured using a combination of metal and polymer materials, which are standard components for this type of orthopedic joint replacement device.
What is the regulatory status of the Apex Knee System?
The Apex Knee System has received FDA 510(k) clearance under k-number K201611. It is classified as a Class II medical device under product code JWH, indicating it has been found substantially equivalent to legally marketed predicate devices.
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: K201611 FDA 510 (k) - Apex Knee System | Omnilife Science, Apex Knee™ | Total Knee Implant | Corin, Apex Knee System 510 (k) K201611 - FDA.report, Microsoft Word - INSERT-002 rev O knee package insert.doc
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201611 | Class II | Active |
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Manufacturer
- Manufacturer
- OMNIlife science, Inc.
- FDA Applicant
- Omnilife Science
Sources (1)
- FDA 510(k) K201611 24 fields · synced Sep 24, 2026