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510(k) Data Aggregation
K Number
K140585Device Name
CTC TCAT(R)-TPLAN(R) SURGICAL SYSTEM
Manufacturer
CUREXO TECHNOLOGY CORPORATION
Date Cleared
2014-08-18
(164 days)
Product Code
OJP, HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
CUREXO TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TCAT™/TPLAN™ Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
The TCAT™/TPLAN™Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.
Device Description
The TCAT™ TPLAN™ Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, and reaming techniques for the preparation of bone for patients requiring a THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™ , a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision bone preparation possible before and during THA surgical procedures.
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K Number
K140038Device Name
DIGIMATCH ORTHODOC ROBODOC ENCORE SURGICAL SYSTEM
Manufacturer
CUREXO TECHNOLOGY CORPORATION
Date Cleared
2014-05-27
(140 days)
Product Code
OJP, HAW
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
CUREXO TECHNOLOGY CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is intended for use as a device which uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
The DigiMatch™ ROBODOC®/ORTHODOC® Encore Surgical System is indicated for orthopedic procedures in which the broaching/reaming in primary total hip arthroplasty (THA) may be considered to be safe and effective and where references to rigid anatomical structures may be made.
Device Description
The DigiMatch™ ORTHODOC®/ROBODOC® Encore System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, and reaming techniques for the preparation of bone for patients requiring a THA procedure. The system consists of the ORTHODOC® Preoperative Planning Workstation and ROBODOC® , a robotic system composed of an electromechanical arm, electronics control cabinet, computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. ORTHODOC® and ROBODOC® when used according to the instructions for use, make precision bone preparation possible before and during THA surgical procedures.
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