Weber/Stiihmer Femoral Head Prosthesis
FDA 510(k) K830948 · Allo Pro Corp.
510(k) numberK830948
Submission
- Device name
- Weber/Stiihmer Femoral Head Prosthesis
- Applicant
- Allo Pro Corp.
Mchenry, IL, US - Received
- March 24, 1983
- Decision date
- July 12, 1983
- 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
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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 |
|---|---|---|
| K901581 | GSB ElbowJDC · Traditional | 10/22/1990SE |
| K900425 | Surgical Cotton GlovesLYU · Traditional | 09/07/1990SE |
| K900392 | Centering PlugLZN · Traditional | 03/01/1990SE |
| K896669 | Weber PermalockLZO · Traditional | 02/06/1990SN |
| K892644 | Biolox Ceramic BallLZO · Traditional | 10/19/1989SE |
| K885049 | Rs-Cup Acetabular ProsthesisKWA · Traditional | 01/13/1989SE |
| K864999 | Kennedy StemJDI · Traditional | 09/09/1987SE |
| K871453 | Zweymueller-Sl Hip Prosthesis StemKWA · Traditional | 07/13/1987SE |
| K851213 | Zweymuller CupKWA · Traditional | 05/28/1985SE |
| K841391 | Weber-Stuhmer Hip Prosthesis StemJDI · Traditional | 04/13/1984SE |
Questions and answers
When was Weber/Stiihmer Femoral Head Prosthesis cleared by the FDA?
Weber/Stiihmer Femoral Head Prosthesis (K830948) received a 510(k) decision of Substantially Equivalent on July 12, 1983, 110 days after the submission was received.
What is the product code of K830948?
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.