S02 ISS.docx

SPECIAL NOTICE

NOTICE OF INTENT TO SOLE SOURCE

Mako Robotic System

The Department of Veterans Affairs Cleveland Medical Center (CLE VAMC), 10701 East Blvd., Cleveland, OH 44106 intends to solicit and negotiate with only one source under the authority of FAR 13.106(b)(1)(i) - Contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available. The NAICS code is 339113 with a small business size standard of 800. The VA intends to solicit to Stryker, 325 Corporate Drive, Mahwah, New Jersey 07430-2006 and negotiate with for a Mako Robotic System.

The CLE VAMC Surgical Service is seeking the procurement of the Mako Robotic Arm system and applications. This system will extend and enhance the quality, precision and safety of total knee and total hip replacement procedures presently being completed at our facility. This would allow the VA to offer the same competitive Orthopedic service to our veterans that is currently being offered in other VA facilities across the nation and in the private sector.

Mako SmartRobotics™ possesses several key features that differentiate it from other surgery platforms. After a thorough surgical plan is created and approved by the surgeon, the Mako System assists surgeons with executing that plan using AccuStop™ haptic technology. The implant position, tracking and soft tissue balancing are assessed in a virtual 3D model by combining a preoperative CT and intraoperative bone registration. A CT scan uses a combination of 2D and digital geometry processing to generate a 3D image of the body. While plain film radiographs (X-rays) provide a 2D image of the scanned area, anatomic structures may overlap, creating an image which is less detailed than a CT scan. In a CT image, overlapping structures are eliminated, making the internal anatomy easier to visualize. In knee and hip arthroplasty procedures, the femoral version and tibial torsion76 can provide critical guidance when planning a case. Bony anatomic landmarks of the femur and tibia can be clearly identified using 3D imaging technologies. After the surgeon assesses implant size and position in the preoperative plan, the robotic arm is introduced to the surgical site. The robotic arm uses AccuStop™ haptic technology to help ensure only the desired bone is resected. The robotic arm will give resistance, an audible warning and ultimately turn off if the surgeon attempts to move the cutting tool on the robotic arm outside the boundaries created in the preoperative plan. In addition, when the surgeon prepares the bone for the implant, the robotic arm guides the surgeon within the predefined area, allowing for a more accurate and better-aligned knee. The Mako provides the surgeon real-time sensory feedback; places surgeon in complete control; helps ensure proper preparation of the bone; allows for precise placement of the implant; produces minimal blood loss and a smaller scar; helps preserve healthy bone and soft tissue; results in less post-operative pain than manual techniques; provides a quicker recovery and shorter hospital stay.

Please include the following:

· Authorized distributor letter

· Brochure

· Salient characteristics

· Specification sheet

· RFQ

Other persons may identify their interest and capability to respond to this requirement by Wednesday, August 15, 2024, at 5PM EST. Such capabilities information will be used solely for the purpose of determining whether to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time. All inquiries must be submitted by email to Rachelle Hamer at rachelle.hamer@va.gov.

Enter “RFQ 36C25024Q0885| MAKO Robotic System” in the email subject line.