Consensus PCL Subsituting Tibial Insert
FDA 510(k) K953443 · U.S. Medical Products, Inc.
510(k) numberK953443
Submission
- Device name
- Consensus PCL Subsituting Tibial Insert
- Applicant
- U.S. Medical Products, Inc.
Austin, TX, US - Received
- July 17, 1995
- Decision date
- April 26, 1996
- 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 |
|---|---|---|
| K962215 | Consensus Posterior Stabilized Knee-Intercondylar Notch RouterHWE · Traditional | 08/15/1996SE |
| K954818 | Consensus Posterior Stabilized KneeJWH · Traditional | 05/22/1996SN |
| 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 PCL Subsituting Tibial Insert cleared by the FDA?
Consensus PCL Subsituting Tibial Insert (K953443) received a 510(k) decision of Substantially Equivalent on April 26, 1996, 284 days after the submission was received.
What is the product code of K953443?
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.