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510(k) Data Aggregation
K Number
K180127Device Name
TCAT (R) THA Instrument Tray Set
Manufacturer
THINK Surgical Inc.
Date Cleared
2019-03-15
(422 days)
Product Code
KCT
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
THINK Surgical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The THINK Surgical TCAT® THA Instrument Tray Set is intended to protect, organize, and deliver to the surgical field TCAT tools, instruments and accessories. The trays allow sterilization of tools, instruments and accessories, and maintain sterility of the enclosed devices until used. The trays are wrapped with an FDA-cleared sterilization wrap during the pre-vacuum autoclave sterilization process.
Device Description
The TCAT THAT Instrument Tray Set is intended only for use with TSolution One® Surgical System instruments, tools and accessories. These trays are used to enclose and hold the instruments, tools, and accessories in an organized manner during the sterilization process and subsequent storage and transportation to and from the surgical suite. The trays are designed to fit any standard autoclave and are constructed primarily of anodized aluminum meeting biocompatibility requirements and compatible with repeated steam sterilizations. The trays have perforations to facilitate sterilant penetration, evacuation, and drying. Since the trays are perforated, an FDA cleared sterilization wrap must be used to maintain sterility of the contents. The trays have the same size and same basic configuration: a rectangular base with latchable lid. The trays have perforations with an evenly distributed hole pattern on the lid, bottom, and sides to allow sterilant penetration. The bottom surface and interior shelves of the trays contain stanchions designed to separately hold each individual instrument, tool, and accessory for effective sterilant exposure, evacuation and drying during the entire duration of the sterilization process, as well as ease of locating each instrument when placing in or removing from the tray.
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K Number
K170430Device Name
TSolution One Surgical System Model 210
Manufacturer
THINK Surgical Inc.
Date Cleared
2017-03-06
(21 days)
Product Code
OLO, PRE
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
THINK Surgical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TSolution One® Surgical System Model 210 is intended for use as a device that 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/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.
The TSolution One® Surgical System Model 210 is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Surgical System Model 210 is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Surgical System Model 210 facilitates accurate positioning of THA implants, relative to these alignment axes.
Device Description
The TSolution One® Surgical System Model 210 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, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary 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 femoral canal and acetabular cup preparation possible before and during THA surgical procedures.
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K Number
K162195Device Name
TSolution One Cup1 Surgical System
Manufacturer
THINK SURGICAL INC.
Date Cleared
2016-09-14
(40 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
THINK SURGICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TSolution One® Cupl Surgical System is intended for use as a device that 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 surqeon, 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/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.
The TSolution One® Cup1 Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Cup1 Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Cupl Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.
Device Description
The TSolution On® Cup1 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, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary 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 femoral canal and acetabular cup preparation possible before and during THA surgical procedures.
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K Number
K153647Device Name
TSolution One w/ACG+ Surgical System
Manufacturer
THINK SURGICAL INC.
Date Cleared
2016-02-16
(57 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
THINK SURGICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TSolution One™ w/ACG+ Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physicial planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under 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/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.
The TSolution One w/ACG+ Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made. The TSolution One™ w/ACG+ Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One™ w/ACG+ Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.
Device Description
The TSolution One™ w/ACG+ 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, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary 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 femoral canal and acetabular cup preparation possible before and during THA surgical procedures.
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K Number
K150741Device Name
TSolution One w/ACG surgical System
Manufacturer
THINK SURGICAL INC.
Date Cleared
2015-10-22
(213 days)
Product Code
OJP, OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
THINK SURGICAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TSolution One™ w/ACG Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physicial planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under 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/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.
The TSolution One™ w/ACG Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One™ w/ACG Surgical System is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One™ w/ACG Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.
Device Description
The TSolution One™ w/ACG 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, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary 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. TPLANTM and TCAT™ when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.
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