510(k) K013106 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
2 PIECE MODULAR HIP STEM
| Applicant | Howmedica Osteonics Corp., Allendale NJ, US |
| Decision | Substantially Equivalent, Apr 3, 2002 |
| Received | Sep 17, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Sep 14, 2009 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics Cancellous Bone Screw;
Dia 6.5 mm; Lnth: 55 mm; Sterile:
Made in the USA;
Stryker Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430.
The bone screws are optional fixtures that Terminated |
HWC | None listed |
| 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 | None listed |
| 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 | 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.