SAM #HT941026N0081

Sole Source Emergency Procurement: Custom 3D Pelvic Model and Cutting Guides from Onkos Surgical

This opportunity involves an emergency, sole source procurement by the Defense Health Agency (DHA) for a custom medical solution: - Government Buyer: - Defense Health Agency (DHA), Healthcare Contracting Division - West (HCD-W), Echo Branch - Department of Orthopedics Surgery, Naval Medical Center San Diego - OEM Highlight: - ONKOS SURGICAL, INC. is the sole identified manufacturer and supplier - Products/Services Requested: - My 3D Custom Pelvic Model and patient-specific Cutting Guides - Custom, patient-specific surgical model and guides for orthopedic surgery - No part numbers or quantities specified; tailored to a single patient case - Unique/Notable Requirements: - Emergency procurement under Unusual and Compelling Urgency authority - Immediate delivery required to support a critical surgery - No competitive solicitation; other vendors may submit capability statements for future consideration - Classified under NAICS 339113 (Surgical Appliance and Supplies Manufacturing) and PSC 6515 (Medical and Surgical Instruments, Equipment, and Supplies)

Description

Notice of Intent to Sole Source

HT941026N0081

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE PURCHASE ORDER CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division - West (HCD-W), Echo Branch negotiated and award a firm-fixed price Purchase Order to ONKOS SURGICAL, INC., to supply My 3D Custom Pelvic Model and Cutting Guides Naval Medical Center San Diego, CA, in accordance with Federal Acquisition Regulation (FAR) 12.102(b), restricting competition, only one source was available to meet the Government’s needs to:

ONKOS SURGICAL, INC., 77 E HALSEY RD, PARSIPPANY, NJ 07054 USA, UEI: LMJ6FDPJ7943, CAGE: 7RK88

The North American Industry Classification System (NAICS) code for this requirement is 339113 SURGICAL APPLIANCE AND SUPPLIES MANUFACTURING; the business size standard is 800 (# of employees). The Product Service Code (PSC) is 6515 MEDICAL AND SURGICAL INSTRUMENTS, EQUIPMENT, AND SUPPLIES.

This serves as a conformed copy documenting that on July 7, 2026, Naval Medical Center San Diego (NMCSD) received funding and immediately issued an email Notice to Proceed (NTP) to Onkos Surgical, Inc. This action was for the emergency procurement of a My 3D Custom Pelvic Model and patient-specific Cutting Guides, ordered by Dr. Flint for a critical surgery occurring the same day. This sole-source procurement was executed under the Unusual and Compelling Urgency authority (FAR 6.302-2), as any delay to conduct standard competitive procedures would have resulted in severe, unacceptable clinical harm to the patient. 

Delivery Location: Department of Orthopedics Surgery, Naval Medical Center San Diego, CA

Delivery Date: July 7, 2026

Based on market research and previous acquisition history, it was determined that ONKOS SURGICAL, INC., was the only source that could meet the Government’s specialized requirement.

This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required cornea tissue locally. Capability statements shall not exceed six (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to Bobbie Dobberstein at bobbie.s.dobberstein.ctr@health.mil. The closing date for challenges is no later than 10:00 a.m. Pacific Time, July 28, 2026.

NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED.

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