6515--Equipment - Mako Robotic Arm System - Detroit

Page 4 of 5 Notice of Intent to Sole Source Requirement The Department of Veterans Affairs, VA Healthcare System, Network Contracting Office 10, intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 13.106-1(b)(1)(i), Soliciting from a Single Source for the items listed below. The associated NAICS code for this is 339112. The vendor will be Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. REQUIREMENT: The MAKO Robotic Arm System (3 App) Total Knee/Partial Knee/Total Hip: 1 RIO Surgical Arm 1 RIO Guidance Module 1 RIO Camera Stand Assembly 1 RIO Accessory Kit 1 ROBOT Utilities 1.11.1 Software Disk 1 MAKO User Guide 5 Mako Power Trays 1 MAKOplasty CT Scan Kit MAKO Total Knee Application: 1 Mako Total Knee Software License 2 Mako Knee Trays 2 Pelvic Arrays 2 Stryker Leg Positioner Tray Kids 1 Surgeon and Surgical Staff Training, Total Knee Mako Partial Knee Application: 1 RESTORIS Partial Knewe Software License 2

Mako Knee Trays 2 IMP DeMayo Leg Positioner 25 Kits 1 Surgeon & Surgical Staff Training, Knee Mako Total Hip Application: 1 MAKOplasty Total Hip Software License 2 Mako Hip Instrument Kits 2 Mako THA Array Kits 2 Hip End Effector, Variable Angle 1 Surgeon & Surgical Staff Training, Hip There are several features/characteristics of the Mako system, as well as other reasons, which establish it as the only system to satisfy the Government s needs: 1. Mako is a semi-active system. The Mako robotic arm will guide the surgeon to precise bone cuts in total knee replacement. The surgeon utilizes a saw attached to a robotic arm. The robotic arm will have a defined area of resection based on the preoperative CT scan performed. This will minimize the potential for soft tissue injury such as neurovascular injury, ligamentous injury, or tendon injury. The robotic arm will not allow the surgeon to make cuts beyond the defined area of resection established by the preoperative CT scan. 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 torsion 76 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 system 1) provides the surgeon real-time sensory feedback, 2) places the surgeon in complete control, 3) helps ensure proper preparation of the bone 4) allows for precise placement of the implant, 5) produces minimal blood loss and a smaller scar, 6) helps preserve healthy bone and soft tissue, 7) results in less post-operative pain than manual techniques, and 8) provides a quicker recovery and shorter hospital stay. 2. The Mako robotic arm is FDA-approved for both cemented and non-cemented total knee replacement. The trend in current orthopedic surgery is toward the use of non-cemented components to allow bone ingrowth into the knee prosthesis and reduce the incidence of bone -cement interface failure with subsequent loosening and need for revision surgery. It is beneficial especially for the younger and more active patients. 3. The Mako system is utilized as a semi-active system for total knee replacement, partial knee replacement, and total hip replacement. The system will guide the surgeon in performing bone cuts in total knee replacement, partial knee replacement, and in acetabular reaming in total hip replacement. The major competitors of the Mako system do not provide robotic assistance in the performance of hip replacement. The Mako system provides direct surgeon assistance in the placement of the acetabular component by directing the surgeon through the use of a robotic arm in reaming of the acetabulum. The ideal placement of the acetabular cup is determined by the preoperative CT scan and allows for placement of the acetabular cup to reduce the potential for dislocation, optimize the leg length, and minimize the potential for impingement of the femur on the acetabulum. In addition, because the size of the acetabular cup can be determined from the preoperative CT scan, reaming of the acetabulum is minimized, Typically in a traditional hip replacement without the use of computer navigation, the acetabulum is enlarged progressively by 1-2mm increments until the ideal size is obtained, usually based on the size of the femoral head measured at the time of surgery, With the MAKO system, the size of the acetabular cup is determined preoperatively and a single reaming is performed with the predetermined acetabular size based on the pre operative CT scan. This can significantly reduce operative time. In addition, since the placement of the acetabular cup is directed by the robotic arm, the MAKO system allows for the precise placement of the acetabular cup determined by preoperative planning. This will reduce the incidence of cup malposition and associated complications including post op dislocation, premature polyethylene wear, leg length discrepancy, and impingement. 4. Stryker Mako robotic arm was requested for use at the Detroit VA to assist in joint replacement procedures - specifically total hip replacement and total knee replacement. Currently, the three orthopedic surgeons who perform hip and knee replacement surgery use Stryker instrumentation and implants to perform total joint replacement. The Mako robotic arm would be an extension of the instrumentation currently utilized to perform hip and knee replacement at the Detroit VA. Should a problem occur with the robot utilization, the procedure would need to be converted to the traditional type of open procedure which the facility currently performs, utilizing the various instrumentation available for intramedullary and/or extra medullary alignment, bone cuts, prosthetic trials, and prosthesis insertion. The Mako robot was designed to be used with Stryker components. Any of the surgeons utilizing the Mako robotic arm would easily be able to switch to a traditional approach currently used should the need arise. Each company that manufactures prosthetic components supplies their own instrumentation to allow for the appropriate placement of the final prosthesis. The instrumentation utilized for joint replacement can be extensive, and typically 5 or more trays of instruments and prosthetic trials are used during joint replacement. Utilizing a robot system other than the Mako system would not be compatible with the current system for which the three orthopedic surgeons performing joint replacement are currently familiar. To switch from the current system would require retraining of the current orthopedic surgeons performing joint replacement to become familiar with an entirely new system for alignment, bone cuts, and prosthesis insertion. This would be absolutely necessary since there is always a risk of robot failure and the need to convert the robotic-assisted procedure into a traditional instrument-guided procedure. There is a learning curve associated with switching to a new system and during that time procedures would take longer to perform, and patients may be subject to a higher rate of adverse event, which is not in the patient s best interest. Each system has its own nuances and experience using a system helps to provide a more fluid surgical procedure, reduce operative time, and minimize errors during the surgical procedure. In summary, the Mako robotic system will meet the clinical needs of the Detroit VA. It is the only system that will provide robotic assistance in the performance of both total hip and total knee replacement. There are other systems available that do not provide robotic assistance of total hip replacement. In addition, preoperative evaluation with use of CT scan in hip replacement has the potential to reduce operative times by limiting the amount of reaming to prepare the native acetabulum for placement of the prosthetic cup. The Mako robotic system is a product of Stryker. There are no other companies that produce this specific product. There are other companies that produce computer navigation or robotic arms for joint replacement, however, the Mako robotic system is FDA-approved for total knee replacement both cemented and non-cemented total knee replacement, partial knee replacement, and total hip replacement. A firm fixed price contract with no option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 10:00 am on Tuesday, April 23, 2024. Kellie Konopinski Contracting Officer (734) 222-4330 Kellie.Konopinski@va.gov