ClearanceBrief
Panels › Orthopedic › Product code LZO · Class 2

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

Regulation 888.3353

9510(k)s in 12 months (535 all time)
0recalls in 12 months (177 all time)
168recalls that name a 510(k)
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Top companies in LZO

DateFirm and productCodeLinked 510(k)
Sep 14, 2009Stryker Howmedica Osteonics Corp.
Restoration Modular Conical Distal Bowed Stem. 14 mm x 235 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bo
Terminated
LZOK013106
Sep 14, 2009Stryker Howmedica Osteonics Corp.
Restoration Modular Conical Distal Bowed Stem. 14 mm x 195 mm; Stryker Orthopaedics. Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bo
Terminated
LZOK013106
Jul 27, 2009Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; Catalog Number: 6428-32-02. Orthopedic implant used in total hip arthroplasty.
Terminated
LZOK030724
Jul 14, 2009Biomet, Inc.
Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemen
Terminated
LZOK042091
Jul 14, 2009Biomet, Inc.
Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile, Biomet Orthopedics, Inc., Warsaw, IN; Catalog Number 12-115112. A hip joint metal/ceramic/polymer s
Terminated
LZOK042091
May 21, 2009Stryker Howmedica Osteonics Corp.
Restoration Modular Cone Bodies; titanium Alloy and Hydroxyapatite, Sterile. Catalog number 6276-1-021, Catalog number 6276-1-025, Catalog number 6276-1-219, and Catalog number 6276-1-325. Howmedica
Terminated
LZOK013106
K022549 +1
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Restoration Modular Conical Distal Stem; Sterile, Titanium Alloy. One unit per package. Stryker Ireland Carrigtwohill County Cork, Ireland. Authorized Representative in Europe: Stryker France, Cedex
Terminated
LZOK022549
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Accolade HFx These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthro
Terminated
LZOK050741
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Accolade C CS These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthr
Terminated
LZOK022555
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Primary Secur-fit Plus Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or rev
Terminated
LZOK041170
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Secur-Fit Max Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total h
Terminated
LZOK041170
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Omnifit Normalized Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision to
Terminated
LZOK932519
Nov 21, 2008Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-03 and 00-6428-032-03. The Alumina Ceramic Femoral Heads are modula
Terminated
LZOK030724
Nov 21, 2008Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-02 and 00-6428-032-02. The Alumina Ceramic Femoral Heads are modular c
Terminated
LZOK030724
Nov 21, 2008Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 32 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-01 and 00-6428-032-01. The Alumina Ceramic Femoral Heads are modula
Terminated
LZOK030724
Nov 21, 2008Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-03 and 00-6428-028-03. The Alumina Ceramic Femoral Heads are modula
Terminated
LZOK030724
Nov 21, 2008Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-02 and 00-6428-028-02. The Alumina Ceramic Femoral Heads are modular c
Terminated
LZOK030724
Nov 21, 2008Zimmer Inc.
Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length -3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-01 and 00-6428-028-01. The Alumina Ceramic Femoral Heads are modula
Terminated
LZOK030724
Oct 31, 2008Stryker Howmedica Osteonics Corp.
Hipstar V40 Femoral Stem Howemedica: Benoist Girard et Cie; 203 bd de la Grande Selle B.P.8; 14201 Herouville Saint Clair. Used in total and hemi hip arthroplasty for: noninflammatory degenerative j
Terminated
LZOK051223
Jun 7, 2007Wright Medical Technology Inc
Profemur R, Revision Hip system, Proximal Body (part), STD 4, REF: PPW38354, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only. Hip implant.
Terminated
LZOK003016
Jun 7, 2007Wright Medical Technology Inc
Profemur R, Revision Hip system, Proximal Body (part), X-Small model, REF: PPW38364, Cementless, Titanium Plasma Spray Coated, Sterile, Rx only Hip implant.
Terminated
LZOK003016
Jul 20, 2004Centerpulse Orthopedics, Inc
RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas
Terminated
LZOK022985
Jul 20, 2004Plus Orthopedics
Biolox Ceramic Head XL
Terminated
LZONone listed
Jul 20, 2004Stryker Howmedica Osteonics
Restoration T3 Revision Hip System, Femoral Hip Prosthesis. Various lengths and Model numbers. 6260-3-014 T3 MOD REV DIST STM 14MMX225MM; 6260-3-015 T3 MOD REV DIST STM 15MMX225MM; 6260-3-016
Terminated
LZOK013106
K983404
Jan 23, 2003Zimmer Inc.
Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.5 neck length on Co-Cr tapers. Cat. No. 6418-28-03
Terminated
LZONone listed
Jan 23, 2003Zimmer Inc.
Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a +3.0 neck length on Co-Cr 12/14 tapers. Cat. No. 6418-26-03.
Terminated
LZONone listed
Jan 23, 2003Zimmer Inc.
Zimmer Alumina ceramic femoral head; 26 mm diameter alumina head with a 0 neck length on Co-Cr 12/14 tapers . Cat. No. 6418-26-02.
Terminated
LZONone listed

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