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510(k) Data Aggregation
K Number
K142587Device Name
Vertical Expandable Prosthetic Titanium Rib
Manufacturer
Depuy Synthes Spine, Inc.
Date Cleared
2014-11-18
(64 days)
Product Code
MDI
Regulation Number
888.3070Why did this record match?
Applicant Name (Manufacturer) :
Depuy Synthes Spine, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VEPTR/VEPTR II device is indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of Thoracic Insufficiency Syndrome (TIS). TIS is defined as the inability of the thorax to support normal respiration or lung growth. This would include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.
Device Description
In children with or at risk of developing Thoracic Insufficiency Syndrome, the natural course of lung development is arrested due to constriction by the thorax. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
The VEPTR devices are attached perpendicularly to the subject's natural ribs and lumbar vertebra or pelvis. This mechanically stabilizes the chest wall and enlarges the thorax to improve respiration and lung growth. Once the VEPTR/VEPTR II device is in place, its design allows for expansion, anatomic distraction, and replacement of component parts through less invasive surgery.
The VEPTR/VEPTR II devices allow assembly in a number of different configurations. All of these configurations are required to accommodate the wide variety of anatomical deformities encountered by the clinician in treating patients with or at risk of developing Thoracic Insufficiency Syndrome.
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