Search Results
Found 3 results
510(k) Data Aggregation
K Number
K250879Device Name
Paradigm System
Manufacturer
Proprio, Inc.
Date Cleared
2025-06-04
(72 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Proprio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
Device Description
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.
The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.
The Paradigm System is used with an external monitor.
Ask a Question
K Number
K243258Device Name
Paradigm System
Manufacturer
Proprio, Inc.
Date Cleared
2025-02-21
(129 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Proprio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
Device Description
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement.
The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories.
The Paradigm System is used with an external monitor.
Ask a Question
K Number
K222291Device Name
Paradigm System
Manufacturer
Proprio, Inc.
Date Cleared
2023-04-21
(263 days)
Product Code
OLO
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
Proprio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons during open surgical procedures with appropriate bone preparation. The device is indicated for posterior approach spine surgery where reference to a rigid anatomical structure that can be identified on CT derived patient images for pedicle screw cannulation of the thoracic to sacrum vertebrae.
Device Description
The Paradigm System is a stereotaxic image guidance system intended for the spatial positioning and orientation of spinal surgical instruments used by surgeons. The Paradigm System fuses high-resolution, real-time camera imaging of the surgical site (such as the spine) with medical imagery (such as CT) and surgical navigation data, such as predetermined instrument trajectories for precise instrument placement. The Paradigm System encompasses non-sterile operating room equipment components as well as sterilizable, reusable instruments, and off-the-shelf sterile-packaged, single-use accessories. The Paradigm System is used with an external monitor.
Ask a Question
Page 1 of 1