FDA.report

510(k) K243615

Device
Physica Porous Femoral Components
Applicant
Lima Corporate S.P.A.
510(k) number
K243615
Product code
MBH
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-18
Date received
2024-11-22
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Massimo Rosso
Address
Via Nazionale, 52 Villanova Di San Daniele IT 33038 33038

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
K242543Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)Zimmer, Inc.2024-11-22
K242412Agility Symmetric™ Total Knee SystemMedisurge, LLC2024-11-06
K243247Persona the Personalized Knee SystemZimmer, Inc.2024-10-29