Hpi, Inc.

Hpi, Inc. primarily manufactures polymeric spinal interbody fusion cages, including devices labeled as SUPSTANCE in both small and large sizes. These are used in spinal fusion procedures to support bone healing. Additionally, the company produces powder-free nitrile gloves, which are a common Class I medical device for hand protection.

Hpi, Inc. is based in the United States, meaning its devices are subject to FDA regulation. The FDA oversees medical devices in the U.S., requiring manufacturers to comply with specific classification rules—such as Class I (lower risk) or Class II (moderate risk)—and registries like the 510(k) premarket notification process and the Unique Device Identifier (UDI) system for tracking.

Hpi, Inc.’s devices appear in the FDA’s 510(k) and UDI registries. The 510(k) process is used for devices determined to be substantially equivalent to existing cleared products, ensuring they meet safety and effectiveness standards before market entry. The UDI system assigns a unique identifier to each device to improve tracking, transparency, and post-market surveillance.

Hpi, Inc.’s devices are classified as either Class I or Class II under FDA regulations. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and performance—such as spinal interbody fusion cages, which require validation of structural integrity and biocompatibility.