Arthrex, Inc. - FDA 510(k) Cleared Devices

Arthrex, Inc. is a medical device manufacturer based in Naples, US. The company specializes in surgical implants and instruments for orthopedic procedures.

Arthrex has received 344 FDA 510(k) clearances from 348 total submissions since its first clearance in 1992. The company's portfolio is dominated by Orthopedic devices, which represent 89% of its regulatory submissions. Recent cleared devices include suture anchors, plating systems, nails, and specialized fixation devices for shoulder, ankle, and lower extremity procedures. The latest FDA 510(k) clearance was received in 2026, confirming active regulatory engagement.

The company's device portfolio reflects core competencies in soft tissue repair, bone fixation, and arthroscopic surgical solutions. Notable product lines include suture anchor systems, humeral and tibia plating systems, and syndesmosis fixation devices.

Explore the complete regulatory record by reviewing individual device names, product codes, and clearance dates in the database.

Regulatory submissions have been managed by Tuv America, Inc. and Mx Orthopedics, Corp.. 1 device has linked clinical trial registered on ClinicalTrials.gov.