Knee, Total, Femoral & Tibial
FDA 510(k) K780904 · Depuy, Inc.
510(k) numberK780904
Submission
- Device name
- Knee, Total, Femoral & Tibial
- Applicant
- Depuy, Inc.
Walker, MI, US - Received
- May 30, 1978
- Decision date
- June 22, 1978
- 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 |
| 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 |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K043058 | Pinnacle Constrained Acetabular LinersKWZ · Traditional | 03/14/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | 12/08/2004SE |
| K041085 | LPS (Limb Preservation System) Lower Extremity Dovetail IntercalaryJWH · Traditional | 07/22/2004SE |
| K033959 | LPSJWH · Traditional | 07/01/2004SE |
| K040544 | Duraloc Option Acetabular Cup System, Models 1599-01-044 to -066, 1599-11-044 to -062…LPH · Traditional | 05/28/2004SE |
| K021478 | Delta ShoulderPHX · Traditional | 11/18/2003SE |
| K033329 | Depuy Ace Universal and Troch Entry Femoral Nail SystemsHSB · Traditional | 11/14/2003SE |
| K032151 | Depuy Sigma Tibial Inserts and Co-Cr Tibial TraysJWH · Special | 09/26/2003SE |
| K020541 | Agility Ankle Revision ProsthesisHSN · Traditional | 05/20/2002SE |
| K011810 | Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial BearingKRO · Traditional | 09/07/2001SE |
Questions and answers
When was Knee, Total, Femoral & Tibial cleared by the FDA?
Knee, Total, Femoral & Tibial (K780904) received a 510(k) decision of Substantially Equivalent on June 22, 1978, 23 days after the submission was received.
What is the product code of K780904?
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.