VSP Hip Stem
FDA 510(k) K903957 · Turnkey Intergration USA, Inc.
510(k) numberK903957
Submission
- Device name
- VSP Hip Stem
- Applicant
- Turnkey Intergration USA, Inc.
Indianapolis, IN, US - Received
- August 28, 1990
- Decision date
- November 26, 1990
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K991405 | Omni-Fix, Humeral NailKTW · Traditional | 06/29/1999SE |
| K990523 | B2C, Espace Revision Cup SystemLPH · Traditional | 04/30/1999SE |
| K990307 | Omni-Fix, Nail SystemKTW · Traditional | 04/01/1999SE |
| K972411 | Link Cement PlugLZN · Traditional | 08/29/1997SE |
| K970284 | Artos, Diplos SystemKWY · Traditional | 04/21/1997SE |
| K970084 | Link Cerclage Wire SystemJDQ · Traditional | 03/13/1997SE |
| K953653 | Lubinus SP II Hip SystemJDG · Traditional | 11/06/1995SE |
| K943986 | Link Endo Model Revision CupHRS · Traditional | 07/05/1995SE |
| K951355 | Link Saddle ProthesisKWL · Traditional | 05/25/1995SE |
| K950397 | System 22 ValveBYE · Traditional | 04/14/1995SE |
Questions and answers
When was VSP Hip Stem cleared by the FDA?
VSP Hip Stem (K903957) received a 510(k) decision of Substantially Equivalent for Some Indications on November 26, 1990, 90 days after the submission was received.
What is the product code of K903957?
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.