Search Results

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The Hanger Cranial Band™ is a thermoplastic helmet prepared with USP Class VI materials; a polypropylene or polypropylene-polyethylene copolymer outer shell. The Hanger Cranial Band™ was initially cleared on December 8, 2000, under 510(k) K001669. This submission provides for the use of a hand held 3-dimensional laser scanner to acquire accurate measurements and a CAD/CAM system to fabricate the orthosis. A medium density polyethylene foam inner lining is thermo-bonded to this shell. The device is custom fabricated for individual patients by obtaining accurate measurements via a hand held 3-dimensional laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The addition of digital imaging allows for increased clinical accuracy and objective clinical documentation. The scan is then modified utilizing a CAD/CAM technology package. The 3-dimensional cranial scan is modified utilizing computer aided design tools to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial band/orthosis. Modifications include but are not limited to: relief areas opposite of cranial bossing, circumference modifications for growth and remolding, suspension, and rotational modifications. The modified file is then emailed to the central manufacturing facility for fabrication and delivery. The modified file measurements are validated and a positive model carved for fabrication. The carved model is evaluated for clinical accuracy and used to fabricate the definitive orthosis. The definitive Hanger Cranial Orthosis is processed through a quality control check list to ensure clinical accuracy, appropriate fabrication techniques, and quality assurance. The Hanger Cranial Band is sent to the practitioner for patient fit and delivery. A digital record of each patient scan and modifications will be maintained on file at Hanger for each patient.