Onkos Surgical, Inc.

Warning LetterOpen

Patrick J. Treacy President and CEO Onkos Surgical, Inc. 77 E Halsey Rd Parsippany , NJ 07054 United States ptreacy@onkossurgical.comFEI 3013450937Issued Jul 21, 2025Center for Devices and Radiological Health

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Violations4

Issue DateJul 21, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Onkos Surgical, Inc.
Location: Patrick J. Treacy President and CEO Onkos Surgical, Inc. 77 E Halsey Rd Parsippany , NJ 07054 United States ptreacy@onkossurgical.com
FEI Number: 3013450937
Country: United States
Issue Date: July 21, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Summary

Onkos Surgical, Inc. was cited for manufacturing the ELEOS Limb Salvage System (used in hip and knee replacement surgery) in violation of FDA's Quality System Regulation (21 CFR Part 820), with the company's devices deemed adulterated due to non-conforming manufacturing, storage, and control procedures. During a two-month inspection from February through April 2025, FDA investigators identified failures in the company's supplier control procedures, specifically noting the firm's inability to ensure that purchased products and services met specified quality requirements. The company submitted a response in May 2025 addressing the initial Form FDA 483 observations, though the violations were serious enough to warrant formal warning letter enforcement rather than closure.

Onkos Surgical, Inc. FDA Warning Letter, July 21, 2025