Consensus 26MM Cocrmo Femoral Head
FDA 510(k) K960151 · U.S. Medical Products, Inc.
510(k) numberK960151
Submission
- Device name
- Consensus 26MM Cocrmo Femoral Head
- Applicant
- U.S. Medical Products, Inc.
Austin, TX, US - Received
- January 11, 1996
- Decision date
- February 21, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3350
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | Biomet Orthopedics, Inc. | 08/24/2026SE |
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | Biomet, Inc. | 07/01/2026SE |
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | Signature Orthopaedics Pty, Ltd. | 03/12/2026SE |
| K243571 | Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersJDI · Traditional | Zimmer Biomet | 07/31/2025SE |
| K240783 | Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip…JDI · Traditional | Smith & Nephew, Inc. | 10/21/2024SE |
| K241716 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge…JDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 08/02/2024SE |
| K240418 | Stryker Orthopaedics Hip Systems Labeling UpdateJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/12/2024SE |
| K233261 | Global Modular Replacement SystemJDI · Traditional | Howmedica Osteonics Corp. A.K.A. Stryker… | 12/08/2023SE |
| K222056 | Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge KneeJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/26/2023SE |
| K220216 | C-Stem AMT LE ProsthesisJDI · Traditional | Depuy Ireland UC | 07/22/2022SE |
More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K962215 | Consensus Posterior Stabilized Knee-Intercondylar Notch RouterHWE · Traditional | 08/15/1996SE |
| K954818 | Consensus Posterior Stabilized KneeJWH · Traditional | 05/22/1996SN |
| K953443 | Consensus PCL Subsituting Tibial InsertJWH · Traditional | 04/26/1996SE |
| K960302 | Consensus Acetabular Shell, All UhmwpeJDI · Traditional | 04/01/1996SE |
| K952943 | Consensus All Poly TibiaJWH · Traditional | 04/01/1996SE |
| K960340 | Consensus Apex Dome Hole PlugJDI · Traditional | 03/15/1996SE |
| K960339 | Consensus 22MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K960156 | Consensus 32MM Cocrmo Femoral HeadJDI · Traditional | 02/21/1996SE |
| K955386 | Consensus Zirconia Femoral HeadLZO · Traditional | 02/20/1996SN |
| K953792 | Consensus Zirconia Head Size -3.5, 0, +5LZO · Traditional | 11/06/1995SN |
Questions and answers
When was Consensus 26MM Cocrmo Femoral Head cleared by the FDA?
Consensus 26MM Cocrmo Femoral Head (K960151) received a 510(k) decision of Substantially Equivalent on February 21, 1996, 41 days after the submission was received.
What is the product code of K960151?
The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.