P.M. Hip-Femoral Prosthesis
FDA 510(k) K853916 · Advanced Biosearch Assn.
510(k) numberK853916
Submission
- Device name
- P.M. Hip-Femoral Prosthesis
- Applicant
- Advanced Biosearch Assn.
Danville, CA, US - Received
- September 23, 1985
- Decision date
- December 27, 1985
- 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
| 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 |
|---|---|---|
| K905514 | Autogenesis(Tm) AutomatorKTT · Traditional | 04/02/1991SE |
| K883888 | Cathscanner Intravascular Ultrasonic Imaging Syst.DXK · Traditional | 12/12/1988SE |
| K854770 | Martin Laminar Osteosynthesis SystemKWP · Traditional | 02/11/1986SE |
| K855030 | Champy Bone Plates & Bone ScrewsJEY · Traditional | 01/30/1986SE |
| K855031 | Manual Surgical Instruments & Access.Champy Bone PHWC · Traditional | 01/21/1986SE |
| K852839 | Freeman HipJDI · Traditional | 10/29/1985SE |
| K853418 | Safti-BraceletKMK · Traditional | 09/20/1985SE |
| K852517 | CLS Hip ProsthesisJDI · Traditional | 09/18/1985SE |
| K852699 | Freeman Acetabular CupKWA · Traditional | 09/05/1985SE |
| K850773 | PM Cementless Screw-In Acetabular CupKWA · Traditional | 05/02/1985SE |
Questions and answers
When was P.M. Hip-Femoral Prosthesis cleared by the FDA?
P.M. Hip-Femoral Prosthesis (K853916) received a 510(k) decision of Substantially Equivalent on December 27, 1985, 95 days after the submission was received.
What is the product code of K853916?
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.