Optimotion Implants, LLC
Orlando, FL, US
OPTIMOTION IMPLANTS, LLC appears in FDA device records in Orlando, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Optimotion Implants, LLC between 2020 and 2024. The busiest year on record is 2020, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K240938 | The Optimotion™ Blue Plus Knee System | MBH | Substantially Equivalent | |
| K220049 | Optimotion Implants Porous Metal-Backed Patella | MBH | Substantially Equivalent | |
| K191084 | The Optimotion Blue Total Knee System | MBH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3016470314 | 3016470314 | OPTIMOTION IMPLANTS, LLC | 6052 Turkey Lake Road, Orlando, FL 32819 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- OIYProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain