FDA.report

510(k) K223548

Device
GMK Sphere & GMK SpheriKA Cementless
Applicant
Medacta International S.A.
510(k) number
K223548
Product code
MBH
Decision
Substantially Equivalent (SESE)
Decision date
2023-01-20
Date received
2022-11-25
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) CH CH-6874 CH-6874

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code MBH

510(k)DeviceApplicantDecision date
K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.2026-03-09
K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.2026-02-26
K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker Orthopaedics2026-02-18
K253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.2025-12-23
K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.2025-12-19
K252777Freedom Metaphyseal Cone Implants (Metaphyseal Cones)Maxx Orthopedics, Inc.2025-10-31
K252044Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics2025-10-24
K243656U2 Total Knee System – PF+ Patella; USTAR II System– PF+ PatellaUnited Orthopedic Corporation2025-07-31
K250980Physica System (Physica CR Porous Femoral components)Lima Corporate S.P.A.2025-05-22
K243768iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement SystemRestor3D, Inc.2025-03-27
K241597Freedom® Total Knee System - Porous Tibial Base PlateMaxx Orthopedics, Inc.2025-02-13
K243293Zimmer® Persona® Personalized Knee SystemZimmer Biomet2024-12-20
K243615Physica Porous Femoral ComponentsLima Corporate S.P.A.2024-12-18
K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.2024-11-22
K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC2024-11-06