510(k) K251840
- Device
- Zimmer® Persona® Personalized Knee System
- Applicant
- Zimmer, Inc.
- 510(k) number
- K251840
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-28
- Date received
- 2025-06-16
- 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
- N
Applicant Contact#
- Contact
- Dora Hu
- Address
- 1800 W. Center St. Warsaw IN US 46580 46580
FDA Registration Numbers#
- 3010041693
- 1720929
- 2183946
- 3025603301
- 3009475821
- 3016090213
- 3008812251
- 1000200989
- 1220477
- 2245304
- 3005596372
- 3008281151
- 3010220595
- 3009732568
- 1220246
- 3021008900
- 1047843
- 3015806723
- 9680215
- 1226188
- 3009293341
- 2648920
- 1644408
- 1038671
- 3010123256
- 3006015326
- 3009813841
- 3011724582
- 3012491394
- 3010039400
- 3011683674
- 2246552
- 3016851379
- 3012329926
- 8010379
- 3020703621
- 2242737
- 3019006180
- 3022142628
- 3011061242
- 3002579136
- 3009848551
- 3004153240
- 9610612
- 1057425
- 3007913880
- 1832228
- 1834331
- 1835444
- 1020279
- 1646498
- 3010386387
- 3002993234
- 1643817
- 3004153896
- 2244478
- 3015231789
- 3014162916
- 3013417938
- 1000517406
- 1818910
- 3017410889
- 1054811
- 3000264985
- 3008658204
- 1319660
- 2183744
- 3036773273
- 3009923578
- 3006395932
- 3030412764
- 2032093
- 1643264
- 3005180920
- 3010173425
- 1833920
- 3015516266
- 3006791286
- 3005279746
Source Documents#
Other 510(k) Records For Product Code MBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K242412 | Agility Symmetric™ Total Knee System | Medisurge, LLC | 2024-11-06 |