Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component
FDA 510(k) K962557 · Smith & Nephew Richards, Inc.
510(k) numberK962557
Submission
- Device name
- Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- July 1, 1996
- Decision date
- December 5, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| K965224 | Empower Anterior Direct ScrewsKWP · Traditional | 05/08/1997SE |
| K963509 | Global Taper Tapered Hip System, GT SpectronLPH · Traditional | 01/27/1997SE |
| K960444 | Finn Rod to Rod ConnectorKWP · Traditional | 01/24/1997SE |
| K964163 | Trimax Nail SystemHSB · Traditional | 12/27/1996SE |
| K963486 | Revision Hip SystemJDI · Traditional | 11/27/1996SE |
| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | 09/17/1996SE |
| K962808 | Ilizarov External Fixation SystemKTT · Traditional | 08/19/1996SE |
| K962137 | Genesis II Constrained SystemJWH · Traditional | 08/02/1996SE |
| K955767 | Cofied Modular Shoulder SystemKWS · Traditional | 04/08/1996SN |
| K960094 | Reflection Dual Dimension ShellMBL · Traditional | 03/27/1996SE |
Questions and answers
When was Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component cleared by the FDA?
Genesis II Zirconium Femoral Component/Profix Zirconium Femoral Component (K962557) received a 510(k) decision of Substantially Equivalent for Some Indications on December 5, 1996, 157 days after the submission was received.
What is the product code of K962557?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.