510(k) K250980
- Device
- Physica System (Physica CR Porous Femoral components)
- Applicant
- Lima Corporate S.P.A.
- 510(k) number
- K250980
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2025-05-22
- Date received
- 2025-03-31
- 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
- Simone De Marco
- Address
- Via Nazionale, 52 Villanova Di San Daniele IT 33038 33038
FDA Registration Numbers#
- 3008812251
- 3007923096
- 3010386387
- 3004748528
- 1721676
- 3005581234
- 1722511
- 9617840
- 1020279
- 3005061536
- 3009760038
- 1219655
- 1423662
- 3008395353
- 1835572
- 1835251
- 3011683674
- 3003541440
- 3013417938
- 2246552
- 3020155054
- 3012130008
- 3010856250
- 3023852420
- 1833920
- 3048147961
- 3010155661
- 3014302784
- 3002807310
- 1424263
- 2244478
- 1226188
- 3010220595
- 3010041693
- 3009582259
- 3005180920
- 3005360851
- 3019006180
- 2032093
- 3006017180
- 2134285
- 3004153896
- 3042172882
- 3009173317
- 3002807314
- 1057425
- 3030412764
- 1531174
- 3009887475
- 1643817
- 9616671
- 3008658204
- 3002806603
- 3002808022
- 3011061242
- 3009555440
- 3010009693
- 3003998208
- 2245304
- 3008281151
- 3007539489
- 3013176080
- 3009973336
- 3008544874
- 3000264985
- 9681465
- 3006801265
- 3009973505
- 3011015572
- 3009882462
- 9680215
- 3016090213
- 3005718816
- 3012319330
- 3009656988
- 3002806470
- 1061927
- 1818910
- 3000236920
- 3003639920
Source Documents#
Other 510(k) Records For Product Code MBH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261275 | Unity Total Knee System, Unity Knee Cementless CR Femur | Corin, Ltd. | 2026-09-17 |
| K261462 | LANDMARK Total Knee System | Smith & Nephew, Inc. | 2026-09-08 |
| K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026-08-21 |
| 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 |
| 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 |