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KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Class II

FDA Device Classification

Classification Details

Product Code
KWZ
Device Class
Class II
Regulation Number
888.3310
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K241461medacta internationalMpact Constrained LinerJuly 31, 2025
K240639depuy ireland ucPINNACLETM Constrained Acetabular LinersApril 4, 2024
K162641smith and nephewSmith & Nephew, Inc. R3™ Constrained LinerJune 19, 2017
K163497encore medical, l.pEXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset March 2, 2017
K161610encore medical, l.pEXPRT Revision Hip SystemNovember 9, 2016
K122139smith and nephewSMITH & NEPHEW R3 CONSTRAINED LINERSOctober 16, 2012
K111635smith and nephewSMITH & NEPHEW RJ CONSTRAINED LINERSSeptember 9, 2011
K101730zimmerLONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERSDecember 3, 2010
K083566smith and nephewR3 CONSTRAINED LINER, CONSTRAINED LINERMarch 3, 2009
K072121zimmerTRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINERJanuary 7, 2008
K071059depuy orthopaedicsDEPUY SPA POROUS COATED PROXIMAL SLEEVENovember 9, 2007
K071676exactechEXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSJuly 19, 2007
K071718zimmerTRILOGY LONGEVITY CONSTRAINED LINERJuly 13, 2007
K071117depuy orthopaedicsMODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERSMay 18, 2007
K063550howmedica osteonicsSYSTEM 12 CONSTRAINED ACETABULAR LINERSMarch 8, 2007
K063445howmedica osteonicsPCA CONSTRAINED ACETABULAR LINERSMarch 8, 2007
K063552howmedica osteonicsSERIES II CONSTRAINED ACETABULAR LINERSMarch 8, 2007
K061654howmedica osteonicsTRIDENT CONSTRAINED ACETABULAR INSERTJuly 7, 2006
K052079depuy orthopaedicsPINNACLE CONSTRAINED ACETABULAR LINERSOctober 21, 2005
K043058depuyPINNACLE CONSTRAINED ACETABULAR LINERSMarch 14, 2005