Modification to: Restoration Modular System
FDA 510(k) K050138 · Howmedica Osteonics Corp.
510(k) numberK050138
Submission
- Device name
- Modification to: Restoration Modular System
- Applicant
- Howmedica Osteonics Corp.
Mahwah, NJ, US - Received
- January 21, 2005
- Decision date
- March 21, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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| 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 |
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| K193429 | Exeter V40 Femoral Stem, Exeter X3 RimFit CupJDI · Traditional | 08/13/2020SE |
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| K130895 | Reunion Rsa Shoulder SystemPHX · Traditional | 12/27/2013SE |
| K123604 | Abg III Monolithic Hip StemMAY · Traditional | 08/16/2013SE |
| K122015 | Distal Femoral Growing Prosthesis, Tibial Rotating Components, Bearing, Axis, Circlip…KRO · Traditional | 02/22/2013SE |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…JWH · Traditional | 02/14/2013SE |
| K122853 | Novel Fit and Fill StemMEH · Traditional | 02/01/2013SE |
| K121315 | Stryker CMF Medpor Customized ImplantFWP · Traditional | 11/01/2012SE |
| K121308 | Hip SystemsLPH · Traditional | 07/30/2012SE |
| K120578 | Accolade II Hip StemJDI · Special | 03/29/2012SE |
Questions and answers
When was Modification to: Restoration Modular System cleared by the FDA?
Modification to: Restoration Modular System (K050138) received a 510(k) decision of Substantially Equivalent on March 21, 2005, 59 days after the submission was received.
What is the product code of K050138?
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.