510(k) K191084
- Device
- The Optimotion Blue Total Knee System
- Applicant
- Optimotion Implants, LLC
- 510(k) number
- K191084
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-04-07
- Date received
- 2019-04-24
- Regulation
- 888.3565
- Classification name
- Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Dan Justin
- Address
- 5931 Brick Ct. Suite 130 Winter Park FL US 32792 32792
FDA Registration Numbers#
- 1226188
- 3002579136
- 3016851379
- 1000200989
- 3007913880
- 3020703621
- 3015806723
- 3006791286
- 3013417938
- 8010379
- 1530390
- 1828288
- 1220477
- 3035366890
- 3012329926
- 3004153240
- 3013055499
- 1835572
- 2032093
- 1018470
- 3010047402
- 1833986
- 3008812251
- 1825034
- 3005279746
- 3007366790
- 3009582259
- 3006801265
- 3005718816
- 3002806603
- 3011015572
- 3002993234
- 3021008900
- 3009923578
- 3007539489
- 3010386387
- 3003639920
- 3009887475
- 3005061536
- 3003998208
- 3008395353
- 3011724582
- 1423662
- 2133928
- 3010856250
- 3016470314
- 9681642
- 3015516266
- 3008544874
- 1720929
- 3007963827
- 9610612
- 3009106092
- 3009848551
- 1043653
- 1054811
- 3014833750
- 1319660
- 2245304
- 3017397663
- 9681465
- 3008658204
- 1424263
- 1643817
- 1450662
- 1219655
- 3026771806
- 3000236920
- 3005360851
- 3004976965
- 3009888740
- 3009293341
- 3036756245
- 2244478
- 3004371426
- 3015231789
- 1531174
- 3011295718
- 3002807310
Source Documents#
Other 510(k) Records For Product Code MBH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251840 | Zimmer® Persona® Personalized Knee System | Zimmer, Inc. | 2026-05-28 |
| K253189 | Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) | Zimmer, Inc. | 2026-03-09 |
| K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026-02-26 |
| K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026-02-18 |
| K253239 | Active-V Total Knee System; World Total Knee System | Signature Orthopaedics Pty, Ltd. | 2025-12-23 |
| K253161 | Balanced Knee System TriMax Porous Femoral Components | Ortho Development Corp. | 2025-12-19 |
| K252777 | Freedom Metaphyseal Cone Implants (Metaphyseal Cones) | Maxx Orthopedics, Inc. | 2025-10-31 |
| K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025-10-24 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | United Orthopedic Corporation | 2025-07-31 |
| K250980 | Physica System (Physica CR Porous Femoral components) | Lima Corporate S.P.A. | 2025-05-22 |
| K243768 | iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System | Restor3D, Inc. | 2025-03-27 |
| K241597 | Freedom® Total Knee System - Porous Tibial Base Plate | Maxx Orthopedics, Inc. | 2025-02-13 |
| K243293 | Zimmer® Persona® Personalized Knee System | Zimmer Biomet | 2024-12-20 |
| K243615 | Physica Porous Femoral Components | Lima Corporate S.P.A. | 2024-12-18 |
| K242543 | Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) | Zimmer, Inc. | 2024-11-22 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases