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510(k) Data Aggregation
K Number
K111437Device Name
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
Manufacturer
Date Cleared
2011-08-10
(78 days)
Regulation Number
888.4540Why did this record match?
Product Code :
HTO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synthes RIA System is intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects, and to remove infected and necrotic bone and tissue from the medullary canal in the treatment of osteomyelitis.
Device Description
Synthes RIA System is a flexible intramedullary reaming and bone harvesting device with simultaneous irrigation and aspiration that consists of disposable tube assemblies, disposable reamer heads, disposable drive shaft seal, disposable locking clip, disposable graft filter and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation as well as the harvesting of bone and bone marrow, and as part of the treatment regimen for osteomyelitis.
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K Number
K042899Device Name
SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS
Manufacturer
Date Cleared
2005-03-16
(147 days)
Product Code
Regulation Number
888.4540Why did this record match?
Product Code :
HTO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis; and to harvest finely morselized autogenous bone and bone marrow for any surgical procedure requiring bone graft to facilitate fusion and/or fill bone defects. These procedures include spinal fusion, joint arthrodesis, total joint replacement, fracture repair, nonunion, maxillofacial reconstruction, and tumor removal.
Device Description
Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads, tube assemblies, drive shaft seals and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The RIA System is also designed to harvest bone and bone marrow. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA System is available in various lengths and diameters.
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K Number
K013527Device Name
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
Manufacturer
Date Cleared
2001-12-21
(59 days)
Regulation Number
888.4540Why did this record match?
Product Code :
HTO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.
Device Description
Synthes RIA System is a flexible reaming device that consists of a series of disposable tube assemblies, disposable reamer heads and reusable drive shafts. The device is designed for expedited reaming of the medullary canal in preparation for internal fixation. The free-rotating reamer head attaches to the distal end of the tube assembly. Ports in the manifold of the tube assembly allow simultaneous irrigation and aspiration through the tube assembly during the reaming process. Irrigating fluid is passed through the cannula of the drive shaft and reamer head and aspiration is drawn through ports of the retainer and aspiration tube. The RIA device is available in reaming diameters ranging from 10 to 19 mm and effective reaming lengths ranging from 200 to 580 mm.
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K Number
K993335Device Name
SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM
Manufacturer
Date Cleared
2000-06-12
(252 days)
Regulation Number
888.4540Why did this record match?
Product Code :
HTO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Synthes RIA System is intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis.
Device Description
The RIA System consists of two types of components; a series of disposable reamer assemblies and reusable drive shafts. The RIA is a device designed for expedited reaming of a medullary canal in preparation of internal fixation. The device includes a free rotating reamer head connected to the distal end of the manifold/tube assembly. The manifold allows both irrigation and aspiration during the reaming process. Irrigation is passed through the cannulation of the reamer and aspiration is drawn from the rear of the flutes in the reamer. The RIA coupled with the Drive Shaft serves as a flexible reaming device and is available in reaming diameters ranging from 9 mm to 24 mm and range in 200 mm to 550 mm in effective reaming lengths.
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