Titan Spine Enhances Endoskeleton Warranty
Titan Spine is amending its spinal device warranty to provide a free replacement if any Endoskeleton® interbody fusion devices delaminate or generate particulate debris during implantation.
Titan Spine first offered the warranty in warranty in 3Q14, to provide a one-time free replacement of an eligible Titan interbody fusion device if revision surgery is required within the 5-year warranty period.
Endoskeleton technology received its first FDA 510(k) clearance under Orthovita in late 2003. Titan Spine was formed to continue use of the Endoskeleton technology that was purchased from Orthovita. (Source: Xconomy)
Titan received its own first 510(k) clearance for an Endoskeleton product in 2009, and secured CE Mark approval for Endoskeleton lumbar interbody fusion devices in 2011. In 2015, the company sold ~10,000 Endoskeleton implants, bringing the total sold to ~44,000 since launch.
The company is preparing to launch next-generation nanoLOCK™ surface technology, which has been shown to offer a variety of benefits compared to applications using PEEK.
Sources: Titan Spine, LLC; ORTHOWORLD Inc.