Development and marketing of minimally invasive systems for orthopedic fracture care using light-curable polymer.

IlluminOss Medical, Inc.

East Providence, RI (USA) · Hilden (DE)New on Amplifa

2007Founded

2Locations (USA, Germany)

CE marking & FDA clearanceRegulatory approvals

About IlluminOss Medical

IlluminOss Medical is a privately held medical technology company in the commercialization phase, specializing in the development and marketing of products for the repair and stabilization of orthopedic fractures. The IlluminOss System is a minimally invasive technology that delivers a light-curable polymer via an expanding balloon catheter, thereby forming a patient-specific, intramedullary implant for bone stabilization. It is specifically designed for the treatment of poor-quality bone, such as in osteoporosis or pathological bone conditions. The procedure is performed through a small, minimally invasive surgical approach and offers patients and clinicians a rapid, patient-specific method of orthopedic bone stabilization. The products are marketed in the EU under CE marking and in the USA under FDA clearance. Founded in 2007, the company is headquartered in East Providence, Rhode Island (USA); for Europe, IlluminOss Medical GmbH in Hilden (Germany) is responsible.

Site: Hilden
Processes: Design and development of orthopedic fracture care products, Minimally invasive fracture repair/stabilization (light-curable polymer in an expanding, After Hours Case Support, Ethics Hotline
Materials: Light-curable polymer
Certificates: CE marking (EU), FDA 510(k) clearance (USA), ISO 13485:2016 (as a mentioned compliance target), ISO 13485:2016
Founded: 2007
Industries: Medical technology, Orthopedics (trauma), Treatment of osteoporotic/pathological bone, Treatment of osteoporotic/pathological bone

01
Design & development of fracture care products
02
Regulatory approval (CE, FDA)
03
Marketing & sales (EU/USA)
04
Clinical support (After Hours Case Support)

Materials & Technologies

LCP

Light-curable polymer

Polymer in the expanding balloon catheter that forms a patient-conforming intramedullary implant through light curing.

Locations

East Providence, RI

Headquarters

Hilden

European location (IlluminOss Medical GmbH)

Industries

Medical technologyOrthopedics (trauma)Treatment of osteoporotic/pathological boneTreatment of osteoporotic/pathological bone

Additional services

Design and development of orthopedic fracture care productsMinimally invasive fracture repair/stabilization (light-curable polymer in an expandingAfter Hours Case SupportEthics Hotline

Quality & Regulatory Affairs

The products are marketed in the EU under CE marking and in the USA under FDA clearance. ISO 13485:2016 is cited as a compliance target in quality management.

Evidence	East Providence, RI
CE marking (EU)
FDA 510(k) clearance (USA)
ISO 13485:2016

History

2007
Foundation of IlluminOss Medical; headquarters in East Providence, RI
2008
Tony O'Leary joins the company
2014
Liane Fuest joins the company