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)
Top companies in LZO
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer GmbH | 34 | 35 |
| Stryker Howmedica Osteonics | 0 | 51 |
| Medacta International | 38 | 0 |
| Exactech, Inc. | 21 | 15 |
| Corin U.S.A. Limited | 27 | 5 |
| Biomet, Inc. | 21 | 8 |
| Howmedica Osteonics | 24 | 2 |
| Smith & Nephew, Inc. | 24 | 2 |
| Microport Orthopedics, Inc. | 13 | 8 |
| Howmedica Corp. | 19 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2009 | Stryker 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 |
LZO | K013106 |
| Sep 14, 2009 | Stryker 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 |
LZO | K013106 |
| Jul 27, 2009 | Zimmer 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 |
LZO | K030724 |
| Jul 14, 2009 | Biomet, 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 |
LZO | K042091 |
| Jul 14, 2009 | Biomet, 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 |
LZO | K042091 |
| May 21, 2009 | Stryker 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 |
LZO | K013106 K022549 +1 |
| Jan 26, 2009 | Stryker 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 |
LZO | K022549 |
| Jan 26, 2009 | Stryker 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 |
LZO | K050741 |
| Jan 26, 2009 | Stryker 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 |
LZO | K022555 |
| Jan 26, 2009 | Stryker 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 |
LZO | K041170 |
| Jan 26, 2009 | Stryker 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 |
LZO | K041170 |
| Jan 26, 2009 | Stryker 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 |
LZO | K932519 |
| Nov 21, 2008 | Zimmer 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 |
LZO | K030724 |
| Nov 21, 2008 | Zimmer 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 |
LZO | K030724 |
| Nov 21, 2008 | Zimmer 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 |
LZO | K030724 |
| Nov 21, 2008 | Zimmer 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 |
LZO | K030724 |
| Nov 21, 2008 | Zimmer 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 |
LZO | K030724 |
| Nov 21, 2008 | Zimmer 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 |
LZO | K030724 |
| Oct 31, 2008 | Stryker 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 |
LZO | K051223 |
| Jun 7, 2007 | Wright 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 |
LZO | K003016 |
| Jun 7, 2007 | Wright 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 |
LZO | K003016 |
| Jul 20, 2004 | Centerpulse Orthopedics, Inc RETi-LOCK Cluster-Hole Acetabular Shells with Sealed Screw-holes manufactured by Zimmer, Austin, Texas Terminated |
LZO | K022985 |
| Jul 20, 2004 | Plus Orthopedics Biolox Ceramic Head XL Terminated |
LZO | None listed |
| Jul 20, 2004 | Stryker 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 |
LZO | K013106 K983404 |
| Jan 23, 2003 | Zimmer 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 |
LZO | None listed |
| Jan 23, 2003 | Zimmer 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 |
LZO | None listed |
| Jan 23, 2003 | Zimmer 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 |
LZO | None listed |
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