Stryker Orthopaedics Hip Systems Labeling Update
FDA 510(k) K240418 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics
510(k) numberK240418
Submission
- Device name
- Stryker Orthopaedics Hip Systems Labeling Update
- Applicant
- Howmedica Osteonics Corp., Dba Stryker Orthopaedics
Mahwah, NJ, US - Received
- February 13, 2024
- Decision date
- April 12, 2024
- 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
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 |
| 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 |
|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | 08/06/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | 07/10/2026SE |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertMBH · Traditional | 02/18/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | 12/15/2025SE |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsMBH · Traditional | 10/24/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | 07/25/2025SE |
| K250989 | Stryker and Serf hip devicesLPH · Traditional | 07/25/2025SE |
| K243817 | Scorpio Universal Dome Patella; Scorpio Total Stabilizer Insert; Scorpio-Flex Posterior…JWH · Traditional | 02/06/2025SE |
| K243784 | Stryker Orthopaedics Hip Devices Labeling UpdateLPH · Traditional | 02/06/2025SE |
| K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…JWH · Traditional | 12/04/2024SE |
Questions and answers
When was Stryker Orthopaedics Hip Systems Labeling Update cleared by the FDA?
Stryker Orthopaedics Hip Systems Labeling Update (K240418) received a 510(k) decision of Substantially Equivalent on April 12, 2024, 59 days after the submission was received.
What is the product code of K240418?
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.