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510(k) K954684

Device
DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT
Applicant
DEPUY, INC.
510(k) number
K954684
Product code
JWH  
Decision
Substantially Equivalent For Some Indications (SN)
Decision date
1996-01-26
Date received
1995-10-11
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
Third party reviewed
No

Applicant Contact#

Contact
DAVID A KOTKOVETZ
Address
P.O. Box 988 700 Orthopaedic Dr. 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
K262057GMK ExtensionMedacta International SA2026-09-15
K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts2026-09-11
K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd.2026-09-10
K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem ExtensionsB-One Ortho, Corp.2026-09-08
K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc.2026-09-04
K253961SK Knee SystemJust Medical Devices (Tianjin) Co., Ltd.2026-09-01
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

Legacy Summary#

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FDA Review#

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