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510(k) Data Aggregation
K Number
K013818Device Name
AUTOGENESIS AUTOMATOR, MODEL M1000
Manufacturer
AUTOGENESIS, INC.
Date Cleared
2001-12-05
(19 days)
Product Code
JEC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AUTOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autogenesis™ Automator™, in conjunction with standard, commercially available circular and unilateral fixation devices, may be used to perform compression or distraction on long bones. The Automator™ may replace Automator™ 2000 or manual distraction and compression devices where they are traditionally applied. Indications for such use include the following:
- the correction of bony or soft tissue deformities,
- limb lengthening by epiphayseal and metaphyseal distraction,
- bone thickening and/or lengthening of amputated stumps,
- fracture fixation (open or closed),
- pseudoarthrosis or non-union of long bones,
- correction of segmental bony or soft tissue defects.
Device Description
Distraction osteogenesis is the process by which our bodies are able to "grow" bone and soft tissues at a fracture site if the bone fragments are gradually separated at a rate approximating 1 mm per day. The Automator is a simple battery powered, motorized device used to accomplish precision distraction for the purpose of bone and soft tissue (re)generation. The programmable device is used as a component on commonly available external fixation frames. Specifically, the device accomplishes micro-adjustments of a telescoping rod, which, in turn, positions the external frames, and bone segments to which the frames are attached.
Adjustment of external frames for bone positioning is presently performed with Automator 2000 or manual adjustment techniques. The Automator is a modified version of the Automator 2000. The device is physically smaller in size and weight while retaining the same basic design and safety features of Automator 2000. Additionally, the Automator's user interface has been enhanced to include an LCD and two control buttons. The upgraded interface makes additional rate settings available to the user. A programming option of cyclic motion was added to aid with pseudoarthrosis (non-union) healing.
Modifications to the predicate device include the devices housing, gearing, circuitry, software, and battery supply. The mechanical design of the Automator is very similar to the design of Automator 2000. The design modifications mostly involve miniaturization of Automator 2000.
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K Number
K981423Device Name
AUTOGENESIS AUTOMATOR 2000 MODEL NUMBER SC2000
Manufacturer
AUTOGENESIS, INC.
Date Cleared
1998-05-20
(30 days)
Product Code
JEC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AUTOGENESIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Autogenesis™ Automator™2000, in conjunction with standard, commercially available circular and unilateral fixation devices, may be used to perform compression or distraction on long bones. The Automator™2000 may replace the CF Automator™ or manual distraction and compression devices where they are traditionally applied. Indications for such use include the following:
- the correction of bony or soft tissue deformities,
- limb lengthening by epiphayseal and metaphyseal distraction,
- bone thickening and/or lengthening of amputated stumps,
- fracture fixation (open or closed),
- pseudoarthrosis or non-union of long bones,
- correction of segmental bony or soft tissue defects.
Device Description
Automator 2000 is a simple battery powered, motorized device used to accomplish precision distraction for the purpose of bone and soft tissue (re)generation. The programmable device is used as a component on commonly available external fixation frames. Specifically, the device accomplishes micro-adjustments of a telescoping rod, which, in turn, positions the external frames, and bone segments to which the frames are attached.
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