Global Modular Replacement System
FDA 510(k) K233261 · Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
510(k) numberK233261
Submission
- Device name
- Global Modular Replacement System
- Applicant
- Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics
Mahwah, NJ, US - Received
- September 29, 2023
- Decision date
- December 8, 2023
- 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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| 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 |
| 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
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| K191358 | Trident II Acetabular SystemLPH · Special | 10/24/2019SE |
| K182468 | Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip SystemLPH · Traditional | 03/19/2019SE |
| K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHSX · Traditional | 06/07/2018SE |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsMBH · Traditional | 11/16/2017SE |
| K171768 | Trident® II Acetabular SystemLPH · Traditional | 10/02/2017SE |
| K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsLPH · Traditional | 10/14/2016SE |
Questions and answers
When was Global Modular Replacement System cleared by the FDA?
Global Modular Replacement System (K233261) received a 510(k) decision of Substantially Equivalent on December 8, 2023, 70 days after the submission was received.
What is the product code of K233261?
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.