Townley Total Elbow System
FDA 510(k) K955916 · Biologically Oriented Prostheses
510(k) numberK955916
Submission
- Device name
- Townley Total Elbow System
- Applicant
- Biologically Oriented Prostheses
Port Huron, MI, US - Received
- December 29, 1995
- Decision date
- August 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDC – Prosthesis, Elbow, Constrained, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3150
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181362 | TEMA Elbow SystemJDC · Traditional | Lima Corporate S.P.A. | 02/16/2019SE |
| K181307 | Zimmer Nexel Total Elbow, Connrad/Morrey Total ElbowJDC · Traditional | Zimmer, Inc. | 01/28/2019SE |
| K153398 | Comprehensive SRS/Nexel ElbowJDC · Traditional | Biomet Manufacturing Corp | 02/03/2016SE |
| K150501 | Zimmer Nexel Total Elbow Ulnar Cement DiverterJDC · Traditional | Zimmer, Inc. | 04/23/2015SE |
| K123862 | Zimmer Nexel Total ElbowJDC · Traditional | Zimmer, Inc. | 03/12/2013SE |
| K090473 | Discovery Elbow - X-SmallJDC · Special | Biomet Manufacturing Corp | 03/25/2009SE |
| K060696 | Acclaim Total Elbow SystemJDC · Special | DePuy Orthopaedics, Inc. | 04/14/2006SE |
| K053189 | Coonrad/Morrey Total Elbow, Model 8105 SeriesJDC · Special | Zimmer, Inc. | 12/09/2005SE |
| K051975 | Porous Coated Discovery ElbowJDC · Special | Biomet, Inc. | 09/06/2005SE |
| K042664 | LPS Upper ExtremityJDC · Traditional | Depuy, Inc. | 12/08/2004SE |
More from Depuy, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K002325 | Wujin #3 Tibial NailJDS · Traditional | 10/30/2000SE |
| K992144 | Biopro Rimmed Acetabular CompomentLZO · Traditional | 09/22/1999SE |
| K964472 | Riopro Cobalt Trapeziometarcarpal Resurfacing ComponentKYI · Traditional | 02/03/1997SE |
| K962769 | Horizon Hip SystemLPH · Traditional | 10/03/1996SE |
| K954768 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 01/18/1996SE |
| K952731 | Townley All Poly Acetabular CupJDI · Traditional | 12/28/1995SE |
| K953045 | Biopro Hemi-Endo Modular Ceramic HeadLZO · Traditional | 09/27/1995SN |
| K951356 | Various Uhmwp Hip & Knee Joint Prosthesis ModifiedLPH · Traditional | 06/19/1995SN |
Questions and answers
When was Townley Total Elbow System cleared by the FDA?
Townley Total Elbow System (K955916) received a 510(k) decision of Substantially Equivalent on August 8, 1996, 223 days after the submission was received.
What is the product code of K955916?
The FDA product code is JDC – Prosthesis, Elbow, Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3150.