ClearanceBrief
Product code MRA ยท Class 3

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

0510(k)s in 12 months (0 all time)
0recalls in 12 months (23 all time)
0recalls that name a 510(k)
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Top companies in MRA

DateFirm and productCodeLinked 510(k)
Apr 12, 2016Exactech, Inc.
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Terminated
MRANone listed
Apr 12, 2016Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper, Femoral Stem; Catalog Number 160-10-16; For use in primary total hip arthroplasty.
Terminated
MRANone listed
Apr 12, 2016Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem, Catalog Number 160-00-14; For use in primary total hip arthroplasty.
Terminated
MRANone listed
Apr 12, 2016Exactech, Inc.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem, Catalog Number 160-00-13; For use in primary total hip arthroplasty.
Terminated
MRANone listed
Apr 12, 2016Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; For use in primary total hip arthroplasty.
Terminated
MRANone listed
Apr 12, 2016Exactech, Inc.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use in primary total hip arthroplasty.
Terminated
MRANone listed
Feb 20, 2014Zimmer, Inc.
VERSYS HERITAGE FEM STEM
Terminated
MRANone listed
Feb 4, 2013Zimmer, Inc.
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Terminated
MRANone listed
Feb 4, 2013Zimmer, Inc.
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Terminated
MRANone listed
Apr 22, 2011Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 62 MM O.D., REF 71338962, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Terminated
MRANone listed
Apr 22, 2011Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 56 MM O.D., REF 71338956, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Terminated
MRANone listed
Apr 22, 2011Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 54 MM O.D., REF 71338954, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Terminated
MRANone listed
Apr 22, 2011Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 36 MM O.D. 52 MM O.D., REF 71338952, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Terminated
MRANone listed
Apr 22, 2011Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM O.D. 55 MM O.D., REF 71338950, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06
Terminated
MRANone listed
Apr 22, 2011Smith & Nephew Inc
R3 TM CERAMIC ACETABULAR LINER, BIOLOX FORTE, 32 MM I.D. 48 MM O.D., REF 71338948, STERILE R, QTY (1), Smith & Nephew, Inc., Memphis, TN 38116, 2017/06 Usage: Primary total hip arthroplasty due
Terminated
MRANone listed
Aug 4, 2009Stryker Howmedica Osteonics Corp.
Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.
Terminated
MRANone listed
Sep 5, 2008Encore Medical, Lp
Keramos Replacement Polyethylene Liner, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Terminated
MRANone listed
Sep 5, 2008Encore Medical, Lp
Keramos Replacement Polyethylene Liner, 60mm; Cat. #496-28-060; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Terminated
MRANone listed
Sep 5, 2008Encore Medical, Lp
Keramos Replacement Polyethylene Liner, 56mm; Cat. #496-28-056; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Terminated
MRANone listed
Sep 5, 2008Encore Medical, Lp
Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Terminated
MRANone listed
Sep 5, 2008Encore Medical, Lp
Keramos Replacement Polyethylene Liner, 48mm; Cat. #496-28-048; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Terminated
MRANone listed
Aug 3, 2005Encore Medical, Lp
Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
Terminated
MRANone listed
Aug 28, 2003Wright Medical Technology Inc
Alumina ceramic liner for acetabular shell. This is part of the Transcend ceramic-on-ceramic total hip system.
Terminated
MRANone listed

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