Mark I Total Knee Sys. Arthroplasty
FDA 510(k) K832302 · Advanced Biosearch Assn.
510(k) numberK832302
Submission
- Device name
- Mark I Total Knee Sys. Arthroplasty
- Applicant
- Advanced Biosearch Assn.
Walker, MI, US - Received
- July 14, 1983
- Decision date
- August 16, 1983
- Decision
- Substantially Equivalent (SESE)
- 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 |
| K884824 | Tricon-M Total Knee SystemMBV · Traditional | Richards Medical Co., Inc. | 11/21/1989SN |
| 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 |
| 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 |
|---|---|---|
| K905514 | Autogenesis(Tm) AutomatorKTT · Traditional | 04/02/1991SE |
| K883888 | Cathscanner Intravascular Ultrasonic Imaging Syst.DXK · Traditional | 12/12/1988SE |
| K854770 | Martin Laminar Osteosynthesis SystemKWP · Traditional | 02/11/1986SE |
| K855030 | Champy Bone Plates & Bone ScrewsJEY · Traditional | 01/30/1986SE |
| K855031 | Manual Surgical Instruments & Access.Champy Bone PHWC · Traditional | 01/21/1986SE |
| K853916 | P.M. Hip-Femoral ProsthesisJDI · Traditional | 12/27/1985SE |
| K852839 | Freeman HipJDI · Traditional | 10/29/1985SE |
| K853418 | Safti-BraceletKMK · Traditional | 09/20/1985SE |
| K852517 | CLS Hip ProsthesisJDI · Traditional | 09/18/1985SE |
| K852699 | Freeman Acetabular CupKWA · Traditional | 09/05/1985SE |
Questions and answers
When was Mark I Total Knee Sys. Arthroplasty cleared by the FDA?
Mark I Total Knee Sys. Arthroplasty (K832302) received a 510(k) decision of Substantially Equivalent on August 16, 1983, 33 days after the submission was received.
What is the product code of K832302?
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.