P03 JOFOC Mako Robotic Surgical Arm_Redacted.pdf

This is a Justification and Approval (J&A) document for a sole-source procurement by the Department of Veterans Affairs (VA), Network Contracting Office (NCO) 21, on behalf of the VA Sierra Nevada Healthcare System (VASNHCS) located in Reno, Nevada. The procurement seeks to acquire a Mako Robotic Surgical Arm system from the Original Equipment Manufacturer (OEM), Stryker Orthopaedics, under a new firm fixed-price contract. The estimated value and delivery timeline are redacted, though the anticipated delivery is approximately 90 days after receipt of order. The justification cites FAR 12.102 and is restricted to a single responsible source under 41 USC §3304(a)(1), as only the Mako system meets the government's unique operational requirements.

The J&A demonstrates that VASNHCS requires the Mako Robotic Surgical Arm specifically because it is the only robotic surgical system meeting VA requirements for multiple orthopedic procedures, including partial knee replacements, total hip arthroplasty, and total knee arthroplasty, with FDA approval for all procedures without additional equipment. Market research conducted across multiple databases—including FPDS, SAM.gov, GSA Advantage, SBA, SCMC, and NAC—identified no viable alternatives or small business distributors. Two prior Stryker awards were found (36C25024P1240 from May 2024 and 36C24423P0864 from September 2023), neither competitively solicited. The document includes certifications from the Clinical Nurse Administrator, Contracting Officer, Director of Contracting, and Head of Contracting Activity approving the sole-source justification.