Sole Source Determination – TOPS System

This contract represents a sole‑source acquisition by the University of New Mexico Hospital for the TOPS™ System, a proprietary motion‑preserving lumbar spinal implant manufactured exclusively by Premia Spine Inc. The purchase is valued at $100,000 and spans a three‑year period, with an option to renew. Because the device is the only FDA‑approved solution of its kind, the agency justified the lack of competition on the basis of unique expertise and exclusivity. The agreement is classified as a firm‑fixed‑price services contract for the supply and support of the implant system. • Product: TOPS™ System – motion‑preserving lumbar spinal implant for stenosis and Grade I spondylolisthesis. • Vendor: Premia Spine Inc., 11 Commerce St, Norwalk, CT 06850 (sole manufacturer). • Contract value: $100,000 fixed price, covering three years of device provision and related services, with a renewal option.