FDA.reportPublic FDA data

510(k) K915132

Device
MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM
Applicant
BIOMET, INC.
510(k) number
K915132
Product code
JWH  
Decision
Substantially Equivalent (SESE)
Decision date
1992-02-11
Date received
1991-11-13
Regulation
888.3560
Classification name
Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PATRICIA S.BERES
Address
P.O. Box 587 Airport Industrial Park Warsaw IN US 46581 46581

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JWH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261563Freedom Total Knee System (E-Poly Tibial Liners)Maxx Orthopedics, Inc.2026-08-07
K262251ACTIFY™ Total Knee System, ACTIFY™ 3D Total Knee System (ACTIFY MC Tibial Insert)Globus Medical, Inc.2026-07-31
K261734Klassic Infection Spacer SystemTotal Joint Orthopedics, Inc.2026-07-23
K261458ATTUNE Total Knee System; ATTUNE Cementless Knee SystemDePuy Ireland UC2026-06-25
K261032NovoKnee (SteriKnee)NovoSource2026-04-27
K253793Materialise TKA Guide SystemMaterialise NV2026-01-06
K252974EMPOWR KneeEncore Medical L.P.2025-12-19
K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC2025-11-19
K253314Freedom Infinia™ Total Knee SystemMaxx Orthopedics, Inc.2025-10-29
K253144Freedom® Total Knee System – Titan PCK ComponentsMaxx Orthopedics, Inc.2025-10-22
K252725Stem Extension Line (U2 Total Knee System—PSA Type)United Orthopedic Corporation2025-09-25
K251554Materialise TKA Guide SystemMaterialise NV2025-07-14
K251776EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert)Encore Medical L.P.2025-07-08
K251241EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones)Encore Medical L.P.2025-07-02
K251717Freedom® Total Knee System – Titanium Tibial Base PlateMaxx Orthopedics, Inc.2025-06-26

Legacy Summary#

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FDA Review#

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