Tricon-M Total Knee System
FDA 510(k) K884824 · Richards Medical Co., Inc.
510(k) numberK884824
Submission
- Device name
- Tricon-M Total Knee System
- Applicant
- Richards Medical Co., Inc.
Memphis, TN, US - Received
- November 18, 1988
- Decision date
- November 21, 1989
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- MBV – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, 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 MBV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K010212 | Offset Tibial TrayMBV · Special | Biomet, Inc. | 02/14/2001SE |
| K873429 | Freeman-Samuelson Mark II Press-Fit Total KneeMBV · Traditional | Protek, Inc. | 10/28/1987SE |
| K853730 | Freeman-Samuelson Mark II Press-Fit Total Knee RepMBV · Traditional | Protek, Inc. | 02/18/1986SE |
| K833200 | Tricon M Total Knee SystemMBV · Traditional | Richards Medical Co., Inc. | 11/29/1983SE |
| K831441 | Porocoat Freeman/Samuelson Total KneeMBV · Traditional | Depuy, Inc. | 09/01/1983SE |
| K832302 | Mark I Total Knee Sys. ArthroplastyMBV · Traditional | Advanced Biosearch Assn. | 08/16/1983SE |
| K830726 | Mark I & II Total Knee Replace. SysMBV · Traditional | Advanced Biosearch Assn. | 06/22/1983SE |
| K823837 | RMC Total Knee SystemMBV · Traditional | Richard'S Medical Equip., Inc. | 03/29/1983SE |
| K830408 | Freeman/Samuelson Total KneeMBV · Traditional | Depuy, Inc. | 02/24/1983SE |
| K822583 | Total Knee SystemMBV · Traditional | Richard'S Medical Equip., Inc. | 10/04/1982SE |
More from Richard'S Medical Equip., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896106 | Rogozinski Spinal System, Add'L ComponentsKWP · Traditional | 06/25/1990SN |
| K900628 | Modular Hip SystemLZO · Traditional | 05/09/1990SN |
| K896580 | Uni-Polar HeadLZY · Traditional | 02/15/1990SE |
| K895241 | Intramedullary Hip ScrewKTT · Traditional | 01/04/1990SE |
| K896204 | Zirconia Ceramic Head Add'L SizesLZO · Traditional | 11/20/1989SN |
| K895242 | Pappas Tri-Flange Ventilation TubeETD · Traditional | 11/17/1989SE |
| K893377 | Russell-Taylor Intramedullary Knee Fusion NailsHSB · Traditional | 11/16/1989SE |
| K885069 | Zirconia Ceramic Head (Yitria Stabilized)LZO · Traditional | 09/01/1989SN |
| K892366 | Porous Genesis Stemmed Tibial ComponentJWH · Traditional | 07/19/1989SN |
| K890132 | Porous Genesis Patellar and Stemless Tibial Comp.JWH · Traditional | 07/19/1989SN |
Questions and answers
When was Tricon-M Total Knee System cleared by the FDA?
Tricon-M Total Knee System (K884824) received a 510(k) decision of Substantially Equivalent for Some Indications on November 21, 1989, 368 days after the submission was received.
What is the product code of K884824?
The FDA product code is MBV – Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.