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Orthopedic Computer Controlled Surgical System

Page Type
Product Code
Definition
Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
Physical State
Preoperative Planning Workstation, a robotic arm, electronics control cabinet, display monitor and miscellaneous accessories (such as cutters, drapes, irrigation sets, probes and markers).
Technical Method
The system registers patient anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femeral canal for primary total hip arthroplasty.
Target Area
Orthopedic Surgery - Hard tissue.
Regulation Medical Specialty
Neurology
Review Panel
Orthopedic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).

Orthopedic Computer Controlled Surgical System

Page Type
Product Code
Definition
Pre-operative planning and intra-operative execution of surgical movements with robotically controlled end effectors under user supervision. Alternative to manual planning and broaching/reaming techniques for femoral canal preparation in primary total hip arthroplasty (THA).
Physical State
Preoperative Planning Workstation, a robotic arm, electronics control cabinet, display monitor and miscellaneous accessories (such as cutters, drapes, irrigation sets, probes and markers).
Technical Method
The system registers patient anatomy to a pre-operative surgical plan to guide a robotic arm during the milling of the femeral canal for primary total hip arthroplasty.
Target Area
Orthopedic Surgery - Hard tissue.
Regulation Medical Specialty
Neurology
Review Panel
Orthopedic
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4560
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4560 Stereotaxic instrument

§ 882.4560 Stereotaxic instrument.

(a) Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

(b) Classification. Class II (performance standards).