Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
FDA 510(k) K243571 · Zimmer Biomet
510(k) numberK243571
Submission
- Device name
- Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners
- Applicant
- Zimmer Biomet
Warsaw, IN, US - Received
- November 18, 2024
- Decision date
- July 31, 2025
- 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 |
| 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 |
| K213701 | Exeter® X3® RimFit® CupJDI · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 02/01/2022SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 510(k) | Device | Decision |
|---|---|---|
| K251834 | Persona Partial KneeHSX · Traditional | 08/15/2025SE |
| K251620 | A.L.P.S. Proximal Humerus Plating SystemHRS · Traditional | 07/25/2025SE |
| K250834 | Zimmer Biomet Ceramic Heads (22.2mm diameter)LZO · Special | 04/18/2025SE |
| K243293 | Zimmer® Persona® Personalized Knee SystemMBH · Traditional | 12/20/2024SE |
Questions and answers
When was Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners cleared by the FDA?
Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners (K243571) received a 510(k) decision of Substantially Equivalent on July 31, 2025, 255 days after the submission was received.
What is the product code of K243571?
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.