Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert
FDA 510(k) K963255 · Smith & Nephew, Inc., Orthopaedic Div.
510(k) numberK963255
Submission
- Device name
- Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US - Received
- August 19, 1996
- Decision date
- January 2, 1997
- 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
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|---|---|---|---|
| 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 |
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| K970351 | Global Taper Spectron Hip StemsJDI · Traditional | 02/28/1997SE |
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Questions and answers
When was Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert cleared by the FDA?
Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial Insert (K963255) received a 510(k) decision of Substantially Equivalent for Some Indications on January 2, 1997, 136 days after the submission was received.
What is the product code of K963255?
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.