Medical Device Manufacturer · US , Englewood , CO

Paragon 28, Inc. - FDA 510(k) Cleared Devices

50 submissions · 50 cleared · Since 2017

Total

Cleared

Denied

Paragon 28, Inc. is a foot and ankle surgical device company based in Englewood, US. Established in 2010, the company specializes in innovative solutions for foot and ankle procedures.

Paragon 28 has received 50 FDA 510(k) clearances from 50 total submissions since 2017. The company's portfolio is entirely focused on Orthopedic devices. Recent clearances include plating systems, nail systems, external fixation devices, and total ankle replacement systems. The latest FDA 510(k) clearance was in 2026, reflecting active ongoing regulatory engagement.

The company's product range encompasses fixation systems, implants for deformity correction, trauma solutions, and biologic offerings. Notable product lines include the Gorilla® and Baby Gorilla® plating systems, Phantom® nail systems, and the APEX 3D Total Ankle Replacement System. Paragon 28 also offers the SMART28℠ platform, which integrates artificial intelligence and 3D modeling for surgical planning.

Explore the complete list of cleared device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Musculoskeletal Clinical Regulatory Advisers, LLC and Triani Consulting, LLC.

FDA 510(k) Regulatory Record - Paragon 28, Inc.

50 devices

1-12 of 50