510(k) K253328
- Device
- GMK 3D Metal Tibial Tray Extension
- Applicant
- Medacta International S.A.
- 510(k) number
- K253328
- Product code
- MBH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-02-26
- Date received
- 2025-09-30
- 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
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Stefano Baj
- Address
- Strada Regina Castel San Pietro CH 6874 6874
FDA Registration Numbers
- 1423662
- 1450662
- 1000200989
- 3000236920
- 2242737
- 3005180920
- 2133928
- 3007913880
- 3013176080
- 3017410889
- 3021008900
- 3010386387
- 3010057495
- 3006801265
- 2183744
- 3015916578
- 3013417938
- 1644408
- 3006791286
- 2183946
- 3023852420
- 1834331
- 1226188
- 3003541440
- 1018470
- 3020703621
- 3011461101
- 3010287737
- 3000264985
- 3002993234
- 3013791180
- 3007963827
- 1833920
- 1827096
- 3002579136
- 3015806723
- 3009760038
- 3025603301
- 3005061536
- 3004142400
- 1643264
- 3016090213
- 3026771806
- 1043653
- 1219655
- 9610612
- 2246552
- 3009106092
- 3009293341
- 3014763043
- 1319660
- 2648920
- 1721676
- 3011061242
- 3015516266
- 3005581234
- 3009475821
- 3010041693
- 3006395932
- 3012491394
- 3004976965
- 1064858
- 3002807314
- 3006015326
- 1646498
- 3004153896
- 1832228
- 3007923096
- 3013014058
- 3010039400
- 9613350
- 2249697
- 3010331645
- 3012392319
- 3006694268
- 3007189546
- 3004450489
- 3016438694
- 3009973336
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
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 |
| 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 |
| K243247 | Persona the Personalized Knee System | Zimmer, Inc. | 2024-10-29 |