Porocoat Mark II Total Elbow
FDA 510(k) K872084 · Depuy, Inc.
510(k) numberK872084
Submission
- Device name
- Porocoat Mark II Total Elbow
- Applicant
- Depuy, Inc.
Warsaw, IN, US - Received
- May 29, 1987
- Decision date
- June 25, 1987
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| 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 Porocoat Mark II Total Elbow cleared by the FDA?
Porocoat Mark II Total Elbow (K872084) received a 510(k) decision of Substantially Equivalent for Some Indications on June 25, 1987, 27 days after the submission was received.
What is the product code of K872084?
The FDA product code is JDC – Prosthesis, Elbow, Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3150.