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510(k) K890197

Device
OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT
Applicant
OSTEONICS CORP.
510(k) number
K890197
Product code
KWZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-04-07
Date received
1989-01-17
Regulation
888.3310
Classification name
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAT KRAMER
Address
59 Rte. 17 Allendale NJ US 07401 07401

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KWZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K241461Mpact Constrained LinerMedacta International S.A.2025-07-31
K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC2024-04-04
K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.2017-06-19
K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P.2017-03-02
K161610EXPRT Revision Hip SystemEncore Medical L.P.2016-11-09
K122139SMITH & NEPHEW R3 CONSTRAINED LINERSSmith & Nephew, Inc.2012-10-16
K111635SMITH & NEPHEW RJ CONSTRAINED LINERSSmith & Nephew, Inc.2011-09-09
K101730LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERSZimmer, Inc.2010-12-03
K083566R3 CONSTRAINED LINER, CONSTRAINED LINERSmith & Nephew, Inc.2009-03-03
K072121TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINERZimmer, Inc.2008-01-07
K071059DEPUY SPA POROUS COATED PROXIMAL SLEEVEDePuy Orthopaedics, Inc.2007-11-09
K071676EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGSExactech, Inc.2007-07-19
K071718TRILOGY LONGEVITY CONSTRAINED LINERZimmer, Inc.2007-07-13
K071117MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERSDePuy Orthopaedics, Inc.2007-05-18
K063445PCA CONSTRAINED ACETABULAR LINERSHowmedica Osteonics Corp.2007-03-08

Legacy Summary#

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FDA Review#

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