S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis
FDA 510(k) K951084 · Joint Medical Products Corp.
510(k) numberK951084
Submission
- Device name
- S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis
- Applicant
- Joint Medical Products Corp.
Stamford, CT, US - Received
- March 9, 1995
- Decision date
- May 31, 1995
- 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 |
|---|---|---|
| K955511 | Arthopor I & II Acetabular Cup/Arthopor II Oblong Acetabular CupLPH · Traditional | 02/26/1996SE |
| K954935 | S-Rom Femoral Hip Stem - Size 14 X 8LPH · Traditional | 01/22/1996SE |
| K944321 | S-Rom Noiles Posterior Stabilized Total Knee System IIJWH · Traditional | 08/14/1995SN |
| K951726 | S-Rom ZTP Uhmwpe Acetabular CupJDI · Traditional | 06/21/1995SE |
| K951000 | ZTT I and II Acetabular Cup of the S-Rom Total Hip SystemLPH · Traditional | 04/14/1995SE |
| K941769 | Knee ProthesisJWH · Traditional | 02/01/1995SN |
| K936037 | S-Rom Noiles Cruciate Retaining KneeJWH · Traditional | 10/03/1994SN |
| K934412 | Coated ZT Proximal SleeveLPH · Traditional | 06/03/1994SE |
| K931676 | S-Rom(R) Ztt(Tm) Acetabular Cup-Apical Hole PlugJDL · Traditional | 05/18/1994SE |
| K935078 | S-Rom Total Hip Replacement SystemJDG · Traditional | 03/09/1994SN |
Questions and answers
When was S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis cleared by the FDA?
S-Rom Opc (One-Piece Cemented) II Femoral Hip Prosthesis (K951084) received a 510(k) decision of Substantially Equivalent on May 31, 1995, 83 days after the submission was received.
What is the product code of K951084?
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.