Consensus Posterior Stabilized Knee
FDA 510(k) K954818 · U.S. Medical Products, Inc.
510(k) numberK954818
Submission
- Device name
- Consensus Posterior Stabilized Knee
- Applicant
- U.S. Medical Products, Inc.
Austin, TX, US - Received
- October 20, 1995
- Decision date
- May 22, 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 |
|---|---|---|
| K962215 | Consensus Posterior Stabilized Knee-Intercondylar Notch RouterHWE · Traditional | 08/15/1996SE |
| K953443 | Consensus PCL Subsituting Tibial InsertJWH · Traditional | 04/26/1996SE |
| K960302 | Consensus Acetabular Shell, All UhmwpeJDI · Traditional | 04/01/1996SE |
| K952943 | Consensus All Poly TibiaJWH · Traditional | 04/01/1996SE |
| K960340 | Consensus Apex Dome Hole PlugJDI · Traditional | 03/15/1996SE |
| K960339 | Consensus 22MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960156 | Consensus 32MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960151 | Consensus 26MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K955386 | Consensus Zirconia Femoral HeadLZO · Traditional | 02/20/1996SN |
| K953792 | Consensus Zirconia Head Size -3.5, 0, +5LZO · Traditional | 11/06/1995SN |
Questions and answers
When was Consensus Posterior Stabilized Knee cleared by the FDA?
Consensus Posterior Stabilized Knee (K954818) received a 510(k) decision of Substantially Equivalent for Some Indications on May 22, 1996, 215 days after the submission was received.
What is the product code of K954818?
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.