F-19 Total Hip Prosthesis
FDA 510(k) K903234 · Med-Tek Corp.
510(k) numberK903234
Submission
- Device name
- F-19 Total Hip Prosthesis
- Applicant
- Med-Tek Corp.
Indianapolis, IN, US - Received
- July 23, 1990
- Decision date
- October 10, 1990
- Decision
- Substantially Equivalent (SESE)
- 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
Other 510(k)s with product code JDI
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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 |
|---|---|---|
| K901687 | F-24 Femoral Hip ProsthesisLWJ · Traditional | 09/07/1990SE |
| K901451 | F-20 Cemented Metal-Backed Acetabular CupJDI · Traditional | 08/31/1990SN |
| K900428 | Anesthesia Breathing CircuitsCAI · Traditional | 08/17/1990SE |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | 08/14/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | 08/03/1990SE |
| K901480 | F-20 Total Hip ProsthesisJDI · Traditional | 06/12/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | 06/05/1990SE |
| K901272 | Orion Blade Plate for Tibial OsteotomyKTT · Traditional | 04/23/1990SE |
| K901240 | Astel Non-Metal Backed Acetabular Cup for CementedJDI · Traditional | 03/26/1990SE |
| K894978 | Bacterial FilterCAH · Traditional | 11/02/1989SE |
Questions and answers
When was F-19 Total Hip Prosthesis cleared by the FDA?
F-19 Total Hip Prosthesis (K903234) received a 510(k) decision of Substantially Equivalent on October 10, 1990, 79 days after the submission was received.
What is the product code of K903234?
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.