Consensus Femoral Component, Porous, Cocr/Ti
FDA 510(k) K983004 · Hayes Medical, Inc.
510(k) numberK983004
Submission
- Device name
- Consensus Femoral Component, Porous, Cocr/Ti
- Applicant
- Hayes Medical, Inc.
Sacramento, CA, US - Received
- August 28, 1998
- Decision date
- November 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | 01/31/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | 12/21/2006SE |
| K060635 | Consensus Acetabular Shell SystemLPH · Special | 04/28/2006SE |
| K030151 | Consensus Hip System, Unisyn Hip SystemLZO · Traditional | 04/10/2003SE |
| K030205 | Consensus Unipolar Head, CocrKWL · Traditional | 04/01/2003SE |
| K021466 | Consensus Acetabular Insert, Cross-Linked PolyethyleneLPH · Traditional | 07/24/2002SE |
| K020153 | Consensus Acetablar Shell, Ti CoatedLPH · Traditional | 04/15/2002SE |
| K003649 | Triton Hip SystemLWJ · Traditional | 02/23/2001SE |
| K001456 | Consensus Knee SystemJWH · Traditional | 08/07/2000SE |
| K964395 | Patient Specific Implant (Psi) Hip Femoral ComponentLZO · Traditional | 01/27/1997SE |
Questions and answers
When was Consensus Femoral Component, Porous, Cocr/Ti cleared by the FDA?
Consensus Femoral Component, Porous, Cocr/Ti (K983004) received a 510(k) decision of Substantially Equivalent on November 25, 1998, 89 days after the submission was received.
What is the product code of K983004?
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.