Mets Modular Proximal Femur
FDA 510(k) K121056 · Stanmore Implants Worldwide , Ltd.
510(k) numberK121056
Submission
- Device name
- Mets Modular Proximal Femur
- Applicant
- Stanmore Implants Worldwide , Ltd.
Canton, MA, US - Received
- April 6, 2012
- Decision date
- September 20, 2012
- 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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More from Depuy Ireland UC
| 510(k) | Device | Decision |
|---|---|---|
| K140898 | Patient Specific Distal FemoralKRO · Special | 01/20/2015SE |
| K133152 | JTS Extendible Distal Femoral ImplantKRO · Special | 01/22/2014SE |
| K121765 | Sculptor Robotic Guidance Arm (Rga)OLO · Traditional | 01/11/2013SE |
| K121055 | Mets Modular Total FemurJDI · Traditional | 09/19/2012SE |
| K121029 | Mets Modular Distal FemurKRO · Traditional | 09/19/2012SE |
| K120992 | Mets Smiles Total Knee ReplacementKRO · Traditional | 09/05/2012SE |
| K092138 | JTS Extendeable ImplantKRO · Traditional | 03/22/2011SE |
Questions and answers
When was Mets Modular Proximal Femur cleared by the FDA?
Mets Modular Proximal Femur (K121056) received a 510(k) decision of Substantially Equivalent on September 20, 2012, 167 days after the submission was received.
What is the product code of K121056?
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.