RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem
FDA 510(k) K023085 · Biomet Orthopedics, Inc.
510(k) numberK023085
Submission
- Device name
- RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem
- Applicant
- Biomet Orthopedics, Inc.
Warsaw, IN, US - Received
- September 17, 2002
- Decision date
- October 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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 |
|---|---|---|
| K253515 | Zimmer Biomet OSS Orthopedic Salvage System OsseoTi® Sleeves and AugmentsJDI · Traditional | 08/24/2026SE |
| K252404 | Comprehensive Reverse Shoulder - HA Glenosphere BaseplatesPHX · Traditional | 04/15/2026SE |
| K243761 | A.L.P.S. Small Fragment Plating SystemHRS · Traditional | 02/19/2025SE |
| K223631 | Comprehensive Segmental Revision System(SRS)KWT · Traditional | 07/12/2023SE |
| K200196 | Taperloc® Complete Hip StemsLZO · Traditional | 12/08/2020SE |
| K131393 | Mak Oss Femoral Knee ComponentsKRO · Traditional | 10/24/2013SE |
| K112905 | Compress(R) Segmental Humeral Replacement SystemMBF · Traditional | 05/24/2012SE |
| K080528 | E-Poly Tibial BearingsJWH · Traditional | 06/17/2008SE |
| K072879 | Innervue Diagnostic Scope SystemHRX · Traditional | 01/14/2008SE |
| K070955 | Acid Etched Lag ScrewsHSB · Traditional | 10/12/2007SE |
Questions and answers
When was RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem cleared by the FDA?
RX 90 Femoral Stem and RX 90 Lateralized Femoral Stem (K023085) received a 510(k) decision of Substantially Equivalent on October 17, 2002, 30 days after the submission was received.
What is the product code of K023085?
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.