SMC Femoral Hip Component
FDA 510(k) K971681 · Signal Medical Corp.
510(k) numberK971681
Submission
- Device name
- SMC Femoral Hip Component
- Applicant
- Signal Medical Corp.
Lakeport, MI, US - Received
- May 6, 1997
- Decision date
- December 4, 1997
- 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 |
|---|---|---|
| K203779 | Symmetric Total Knee SystemMBH · Traditional | 06/10/2021SE |
| K100370 | Symmetric Total Knee AgumentsJWH · Traditional | 03/07/2011SE |
| K080199 | Symmetric Total Knee SystemJWH · Traditional | 07/03/2008SE |
| K073674 | Bone Fixation Wire (Kirschner Wire)HTY · Traditional | 03/24/2008SE |
| K051510 | Signal Medical Corporation Beacon Knee SystemMBH · Traditional | 03/22/2006SE |
| K043289 | E-Z Frame External Surgical Support BootKTT · Traditional | 02/11/2005SE |
| K022382 | RHS Acetabular ComponentLPH · Traditional | 10/04/2002SE |
| K021063 | Great Toe ImplantKWD · Traditional | 07/01/2002SE |
| K981302 | SMC 28MM Ceramic Femoral HeadsLZO · Traditional | 06/25/1998SE |
| K971018 | SMC Acetabular ComponentLPH · Traditional | 10/24/1997SE |
Questions and answers
When was SMC Femoral Hip Component cleared by the FDA?
SMC Femoral Hip Component (K971681) received a 510(k) decision of Substantially Equivalent on December 4, 1997, 212 days after the submission was received.
What is the product code of K971681?
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.