Sulzer Orthopedics MS-30 Femoral Stem
FDA 510(k) K001078 · Sulzer Orthopedics, Inc.
510(k) numberK001078
Submission
- Device name
- Sulzer Orthopedics MS-30 Femoral Stem
- Applicant
- Sulzer Orthopedics, Inc.
Austin, TX, US - Received
- April 4, 2000
- Decision date
- June 23, 2000
- 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
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| 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 |
|---|---|---|
| K022985 | Ascendent Acetabular SystemLZO · Traditional | 12/05/2002SE |
| K021578 | Natural-Knee II System Cocr Tibial BaseplateJWH · Traditional | 08/09/2002SE |
| K020713 | MS-30 Lateral Femoral StemLZO · Traditional | 05/14/2002SE |
| K013935 | Allofit Acetabular System 32MM Alpha Durasul InsertsLZO · Special | 12/13/2001SE |
| K013031 | Most Options SystemKRO · Traditional | 12/07/2001SE |
| K012739 | Converge Acetabular SystemLPH · Traditional | 11/14/2001SE |
| K012961 | Sulzer Orthopedics Converge Acetabular SystemJDI · Special | 10/18/2001SE |
| K011954 | Sulzer Orthopedics Allegretto Unicompartmental KneeHSX · Traditional | 09/19/2001SE |
| K010839 | CLS Varus Stem/Cls 135 StemLZO · Special | 04/18/2001SE |
| K003758 | Allofit Acetabular SystemKWA · Traditional | 03/07/2001SE |
Questions and answers
When was Sulzer Orthopedics MS-30 Femoral Stem cleared by the FDA?
Sulzer Orthopedics MS-30 Femoral Stem (K001078) received a 510(k) decision of Substantially Equivalent on June 23, 2000, 80 days after the submission was received.
What is the product code of K001078?
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.