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) |
|---|---|---|---|
| Nov 6, 2012 | Zimmer, Inc. Biolox delta Ceramic Femoral Head
Rx only, sterile Terminated |
LZO | K071535 |
| Nov 6, 2012 | Zimmer, Inc. Alloclassic SL Shaft Terminated |
LZO | K030373 |
| Sep 28, 2012 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Restoration Modular Cone Body Trials
Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland.
The Cone Body Trials simulate the respective Cone Body i Terminated |
LZO | K013106 K022549 +1 |
| Apr 23, 2012 | Biomet, Inc. Ref, S331140 Selex M2A Magnum Modular Head, 40 mm head diameter plus 3 mm neck,1 Taper, Sterile, Biomet Orthopedics, Warsaw, IN
Product Usage:
Intended for use in non-cemented primary and revision Terminated |
LZO | K062997 |
| Mar 2, 2012 | Biomet, Inc. OSS AVL Poly Tibial Bushing Set
OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures. Terminated |
LZO | K062997 |
| Jan 13, 2012 | Ortho Development Corporation U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Ac Terminated |
LZO | K103384 |
| Nov 16, 2011 | Stryker Howmedica Osteonics Corp. Stryker Restoration ADM System Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex France
The Restorati Terminated |
LZO | K072020 |
| Nov 16, 2011 | Stryker Howmedica Osteonics Corp. Stryker Restoration ADM System X3 Acetabular Insert Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 69881 Mey Sieu Cedex Terminated |
LZO | K093644 |
| Nov 16, 2011 | Stryker Howmedica Osteonics Corp. Stryker Modular Dual Mobility (MDM) Liner and X3 Acetabular Insert; Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430; Stryker France ZAC Satolos Green Pusignan Av de Satolas Green 6988 Terminated |
LZO | K103233 |
| Aug 12, 2011 | Aesculap Inc Metha(R) Hip System Cobalt Chrome (CoCr) Metha Modular Neck Adapters used with the Metha Modular Short Hip Stems.
Aesculap AG.
Intended to replace a hip joint Terminated |
LZO | K071916 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0104, Offset Stem Inserter Neutral, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem ins Terminated |
LZO | K062775 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0103, Offset Stem Inserter LT, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter Terminated |
LZO | K062775 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0102, Offset Stem Inserter RT, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter Terminated |
LZO | K062775 |
| Mar 16, 2011 | Ortho Development Corporation Ovation Hip Stem, REF 201-0002, Hip Stem Inserter, Non-Sterile, Ortho Development, Draper, Utah 84020.
The Ovation Hip System is intended for use in total hip arthroplasty. The hip stem inserter is an Terminated |
LZO | K062775 |
| Mar 11, 2010 | Stryker Howmedica Osteonics Corp. Howmedica Osteonics Corp. Restoration Modular Revision Hip System, Plasma Distal Stem; Titanium, Alloy and Hydroxyapatite. Catalog number: 6276-5-014. Terminated |
LZO | K013106 |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. Secur-Fit MAX Secure-FIT Plus Max Surgical Protocol.
Surgical protocols instruct surgeons on proper surgical technique. Terminated |
LZO | K022555 |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. OnmiFit HFx Surgical Protocol 127 degree and 132 degree Surgical Protocol; Stryker, 325 Corporate Drive, Mahwah, NJ 07430.
Surgical protocols instruct surgeons on proper surgical technique. Terminated |
LZO | K022555 |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. OmniFit Eon 127 degree and 132 degree Surgical Protocol;
Stryker.
Surgical protocols instruct surgeons on proper surgical technique. Terminated |
LZO | K022555 |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. CuttingEdge Total Hip Instrumentation Surgical Protocol;
Acetabular and Femoral Surgical Technique for Primary Press Fit and Cemented Hip Implants.
Stryker Howmedica Osteonics.
Surgical protocols ins Terminated |
LZO | K022555 |
| Jan 11, 2010 | Stryker Howmedica Osteonics Corp. Accolade System Surgical Technique;
Accolade C - Cemented Hip Stem;
Accolade TMZF Cementless Hip System;
Accolade HFx Cementless Hip System.
Stryker Orthopaedics.
Surgical protocols instruct surgeons Terminated |
LZO | K022555 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Calcar Body, 21 mm +20 mm;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
29 mm +20 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
27 mm +20 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
25 mm +20 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
23 mm +20 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
21 mm +20 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
29 mm +10 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
27 mm +10 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
25 mm +10 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
23 mm +10 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
21 mm +10 mm;
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
31 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
29 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
27 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
25 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
23 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
21 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System; Proximal Cone Body;
19 mm +0 mm (STD);
Not for use with + 16 V40 femoral Head. For Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or rev Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Calcar Body, 25 mm +20 mm;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Calcar Body, 31 mm +10 mm;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Calcar Body, 27 mm +10 mm;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Calcar Body, 23 mm +10 mm;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Calcar Body, 19 mm +10 mm;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Proximal Broached Body, Size 8;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Proximal Broached Body, Size 7;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Proximal Broached Body, Size 6;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Proximal Broached Body, Size 5;
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well as in the presence of sever proximal bone loss. Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System, Conical Distal Stem, 14 mm x 195 mm; Straight, Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well a Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular Hip System, Conical Distal Stem, 15 mm x 155 mm; Straight, Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty as well a Terminated |
LZO | K013106 |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Restoration Modular hip System, Conical Distal Stem, 14 mm x 155 mm; Straight, Cementless Use Only.
Stryker Orthopaedics.
Intended to be used for primary or revision total hip arthroplasty, as well Terminated |
LZO | K013106 |
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