Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
FDA 510(k) K252824 · Signature Orthopaedics Pty, Ltd.
510(k) numberK252824
Submission
- Device name
- Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head
- Applicant
- Signature Orthopaedics Pty, Ltd.
Lane Cove West, AU - Received
- September 5, 2025
- Decision date
- March 12, 2026
- 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 |
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| 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 |
| 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 |
|---|---|---|
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | 12/23/2025SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | 12/16/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | 08/07/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | 05/13/2025SE |
| K242477 | Shoulder Soft Tissue AnchorsMBI · Traditional | 05/12/2025SE |
| K243043 | Origin Cemented Hip StemLZO · Traditional | 05/02/2025SE |
| K243029 | Origin TT StemLZO · Traditional | 03/11/2025SE |
| K243162 | World LinerMEH · Special | 11/25/2024SE |
| K240683 | Rx Knee SystemJWH · Traditional | 09/11/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | 08/01/2024SE |
Questions and answers
When was Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head cleared by the FDA?
Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head (K252824) received a 510(k) decision of Substantially Equivalent on March 12, 2026, 188 days after the submission was received.
What is the product code of K252824?
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.