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510(k) K033489

Device
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
Applicant
BIOMET, INC.
510(k) number
K033489
Product code
MBH  
Decision
Substantially Equivalent (SESE)
Decision date
2004-06-02
Date received
2003-11-04
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
PATRICIA SANDBORN BERES
Address
56 E. Bell Dr., P.O. Box 587 Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MBH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.2026-05-28
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

Legacy Summary#

summary

FDA Review#

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