Regulatory Status

 

Commercial Status of Arthrosurface's^® Product Line

Arthrosurface^®, Inc. designs, develops and commercializes medical devices for use by prescribing licensed Physicians for the repair of diseased or damaged joints. Arthrosurface's^® products require either prior clearance or approval by the U.S. Food and Drug Administration before commercial distribution in the U.S. can commence. Likewise, commercial distribution is prohibited in member countries of the European Union (E.U.) unless prior approval for such marketing has been granted by an authorized Notified Body after thorough review of product and process design, quality and manufacturing information. Marketing approval for products to be sold in the E.U. shall be evident by affixing a CE mark on the device labeling.

Arthrosurface's^® platform technology, Contoured Articular Prosthetic (CAP^®) Resurfacing System, has been cleared for marketing by the FDA for use in the repair of damaged cartilage surfaces on the long bones of shoulder and hip joints and also for repair of the metatarsal head in the great toe. The product line is referred to as HemiCAP^® because the CAP^® system is used on only one (hemi) of the two opposing surfaces in a joint. Arthrosurface will be submitting additional marketing applications to the FDA for use of the HemiCAP^® system in the repair of lesions or injury in other joints such as the glenoid, spine, ankle and elbow.

Joint	Commercial Status
	United States	European Union	Australia and New Zealand	Canada	Brazil	South Africa
Hip	√	√	√	√	†	√
Shoulder	√	√	√	√	√	√
Great Toe	√	√	√	√	√	√
UniCAP™ Unicondylar Knee	√	√	†	†	†	√
Patello-Femoral - Knee	√	√	√	√	†	√
Femoral Condyle - Knee	*	√	√		†	√

Legend
A check mark symbol (√) indicates that the HemiCAP^® device is commercially available for use in the treatment of the specified joint in that particular market.
A cross (†) indicates that the HemiCAP^® device is expected to be commercially available for use in the treatment of the specified joint in that particular market sometime in the future.
An asterisk (*) indicates that the HemiCAP^® device is considered an Investigational device by the FDA and is currently being evaluated as part of a clinical study at a number of sites in the US.

Note that regulatory approval to commercialize the HemiCAP^® line of devices will be sought in many other countries around the world including Japan, and selected markets in South America & Asia.

Presently, the CAP^® system technology is also in development as a treatment for diseased or damaged femoral condyles. As with other innovative medical devices, clinical evidence of safety and effectiveness shall be required using the HemiCAP^® femoral condyle system before the FDA will grant marketing approval for this indication. The company has submitted an Investigational Device Exemption (IDE) submission to the FDA and is currently enrolling and treating patients.  This does not include the HemiCAP^® Patello-Femoral system which has FDA approval.

 

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