Portland Cobalt Chrome Femoral Head
FDA 510(k) K063278 · Portland Orthopaedics Limited
510(k) numberK063278
Submission
- Device name
- Portland Cobalt Chrome Femoral Head
- Applicant
- Portland Orthopaedics Limited
Stillwater, MN, US - Received
- October 31, 2006
- Decision date
- January 12, 2007
- 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 |
|---|---|---|
| K061564 | Portland Ceramic (Biolox-Forte) Femoral HeadLZO · Traditional | 09/01/2006SE |
| K053417 | M-Cor Hip Replacement SystemLPH · Traditional | 07/20/2006SE |
| K051844 | Equator Plus Acetabular Cup SystemMAY · Traditional | 10/07/2005SE |
| K032641 | Modification to: the Margron Hip Replacement SystemMEH · Special | 01/20/2004SE |
| K992815 | The Margron Hip Replacement SystemMEH · Traditional | 02/07/2000SE |
Questions and answers
When was Portland Cobalt Chrome Femoral Head cleared by the FDA?
Portland Cobalt Chrome Femoral Head (K063278) received a 510(k) decision of Substantially Equivalent on January 12, 2007, 73 days after the submission was received.
What is the product code of K063278?
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.