ACTIS REAMER TRAYS

The Department of Veterans Affairs is conducting a sole-source procurement under FAR 13.106(b)(1)(i) for ACTIS Reamer Trays and associated surgical instrumentation exclusively manufactured by Johnson & Johnson/DePuy Synthes to support total hip arthroplasty procedures at the Cleveland Veterans Affairs Medical Center. The procurement is non-competitive due to the proprietary design of the ACTIS Total Hip System, which requires OEM-specific components such as neck resection guides, reamers (sizes 0 through 13), retaining stem inserters, and the ACTIS Flex Reamer Case Base to ensure technical compatibility, surgical accuracy, and patient safety. No alternative sources exist that can meet the required specifications, and market research confirmed the absence of other vendors capable of supplying compatible instruments, resulting in the determination that the Rule of Two cannot be satisfied and no small business set-aside is applicable. The items must be delivered directly from the original equipment manufacturer to the Cleveland VAMC location at 10701 East Blvd., Cleveland, OH 44106 within 30 days of order placement under an As Required Order (ARO) framework, with packaging and preservation requirements focused on maintaining sterility and functional integrity, though no specific MIL-STD or labeling standards are defined beyond the use of a Local Stock Number for traceability. The Contracting Officer, Rachelle Hamer, of the Network Contracting Office 10 in Dayton, Ohio, is the primary point of contact and has certified the sole-source justification under VA-specific authority RFO 12. While no formal contract clauses, evaluation factors, pricing, or payment details are included in the documentation, the procurement is structured as a firm-fixed-price acquisition with no established contract value since pricing remains to be negotiated post-justification. Interested parties may submit capability statements by July 10, 2026, via email to rachelle.hamer@va.gov with the specified subject line for informational purposes only, but submissions do not constitute a formal response to a solicitation. The instruments are classified under NAICS 339113, and the vendor, Johnson & Johnson/DePuy Synthes, is identified as a large business, with no socioeconomic certifications claimed. All deliverables must meet the manufacturer’s proprietary specifications and comply with FDA regulatory requirements, ensuring seamless integration with existing surgical systems and maintaining standardized sterile processing protocols without deviation.