Data / Medical devices / United States / Optimotion Implants, LLC
Optimotion Implants, LLC: FDA-registered device maker in Orlando, FL, United States, 3 510(k) clearances
Optimotion Implants, LLC is registered with the FDA (registration 3016470314) in Orlando, FL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 27, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016470314
- Address
- 6052 Turkey Lake Road Suite 170, Orlando, FL, United States, 32819
- Owner or operator
- Optimotion Acquisition I, LLC (10095680)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 14, 2026
- Registered through
- 2026
- Brand names listed
- Optimotion Blue Total Knee System, Optimotion Implants Porous Metal-Backed Patella, The Optimotion Blue Plus Knee System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 27, 2024 | K240938 | The Optimotion Blue Plus Knee System | MBH | Substantially Equivalent | Optimotion Implants, LLC | accessdata.fda.gov |
| March 14, 2022 | K220049 | Optimotion Implants Porous Metal-Backed Patella | MBH | Substantially Equivalent | Optimotion Implants, LLC | accessdata.fda.gov |
| April 7, 2020 | K191084 | The Optimotion Blue Total Knee System | MBH | Substantially Equivalent | Optimotion Implants, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- All makers of Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- All makers of Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Updated June 27, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.