510(k) K243247
- Device
- Persona the Personalized Knee System
- Applicant
- Zimmer, Inc.
- 510(k) number
- K243247
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-10-29
- Date received
- 2024-10-11
- 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
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gregory Foster
- Address
- 1800 W. Center St. Warsaw IN US 46580 46580
FDA Registration Numbers#
- 1833920
- 9681642
- 3015231789
- 3003998208
- 1000517406
- 3005061536
- 3002808022
- 3008658204
- 3010047402
- 3009173317
- 2648920
- 1319660
- 1644408
- 3010287737
- 1226188
- 9616671
- 1047843
- 9610726
- 3010041693
- 1226544
- 3035366890
- 3006694268
- 3026771806
- 3003541440
- 9613369
- 3002807314
- 3010123256
- 3009656988
- 3008868758
- 3009973336
- 3005874553
- 3004371426
- 3007923096
- 1643264
- 3010386387
- 1649518
- 1827096
- 3042172882
- 2134285
- 1721676
- 3010375065
- 1818910
- 9681465
- 3006395932
- 3038503932
- 2246552
- 1000200989
- 3007366790
- 9680215
- 1054811
- 1828288
- 3022142628
- 3009848551
- 1529009
- 2133928
- 3016090213
- 3036773273
- 1018470
- 3009582259
- 1531174
- 3020155054
- 3020703621
- 3004748528
- 1835251
- 3005718816
- 3013014058
- 1423662
- 3015916578
- 2528981
- 1043653
- 3011461101
- 3011061242
- 3014833750
- 3006791286
- 3016470314
- 3012319330
- 3009475821
- 2249615
- 3008021110
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 |