Rosa Knee System LSJ FAR 13.5 Brand Name Justification -_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Brand Name Justification >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C244-25-AP-2638

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C244-25-AP-2638

1. Contracting Activity: Department of Veterans Affairs, VISN 4, 595 Lebanon VA Medical Center 1700

S. Lincoln Ave Lebanon, PA 17042.

2237: 595-25-2-480-0096

2. Nature and/or Description of the Action Being Processed: The Lebanon VA Medical Center has a firm fixed price requirement for one (1) Rosa Knee System. The ROSA Knee System is a robotic assistant that helps surgeons perform knee replacement surgery with greater accuracy and a more personalized fit for the patient. The surgeon remains in full control, using the robot as a highly precise tool and guide.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:Supplies need to meet the Lebanon VA Medical Centers needs include:

Part # Description Qty

20802010001 Rosa Recon Platform 110V includes; Rosa knee Optical unit, knee software, knee software upgrade and clinical PC 1

20802008002 Rosa Robotic Unit Cove 1

KT802005000 Rosa Knee General Instr Kit (ROSAGEN) 3

KT802006004 Rosa Knee Persona V1.4 Kit (ROSAGEN) 3

KT802006104 Rosa Knee Nexgen V1.4 Kit (ROSAPSN4) 1

KT802006204 Rosa Knee Vanguard V1.4 Kit (ROSAVG4) 1

20808502000 X-PSI Calibration Kit 1

The estimated dollar value of this acquisition is

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#: 36C244-25-AP-2638

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): The Rosa Knee System, manufactured by Zimmer/Biomet, is an advanced surgical platform exclusively distributed by Red One Medical, an SDVOSB distributor. Notably, the Rosa Knee System is a closed platform, meaning it is only compatible with Zimmer/Biomet implants and instruments, and cannot be integrated with products from other manufacturers. The Lebanon VA Medical Center already utilizes Zimmer products, instruments, and software for knee replacement surgeries. Selecting a different surgical system would require the medical center to replace its entire existing inventory of Zimmer products and instruments, leading to significant additional costs. Moreover, purchasing another brand would necessitate duplicative and uneconomical investments, including acquiring new operating and bench stock inventories of consumables and spare parts unique to the alternative brand. It would also require substantial provider and technician time for training in the use and maintenance of the new equipment, further increasing expenses and operational disruption.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Multiple SDVOSBs were identified, but only one, Red One, is an authorized distributor. A source sought was posted to sam.gov, 36C24425Q0543, with the only responses from the distributor and the OEM. Zimmer Biomet is the sole manufacturer of the Rosa robotic platform. There are no alternative purchase options available outside of the Rosa Knee System. The Rosa Knee System is only approved for use with Zimmer Biomet products.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Based on the pricing from the recently awarded 36C24123P1243 with an award date of 09/25/2023 and the quoted price for the Lebanon VA Medical Center, I can confirm that the pricing is determined to be fair and reasonable. FPDS was surveyed; no additional awards have been made for the Rosa Knee System.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: A sources sought was posted to SAM.gov. A letter was received from Red One stating that they are the sole authorized distributor of the Zimmer Biomet Rosa Knee System. Currently, Red One has an existing SAC Contract, 36C10G24D0040, for Zimmer products but the SAC Contract does not contain the Rosa Knee System. No other robotic knee system can be used that won’t incur additional costs and disposal of Zimmer implants, products, and software. This limited market research is just for the Zimmer Rosa Knee system, which can be provided by the OEM Zimmer Biomet and Red One, the exclusive SDVOSB distributor.

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#: 36C244-25-AP-2638

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: The Rosa Knee System is the only approved system for use with compatible Zimmer Biomet implants as specified in the cleared indications for use statement.

10. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required: The government will continue to conduct market research to ascertain is there are update or changes in the robotic marketplace that would enable future surgical and robotic requirements. All future requirements will be handled on a case-by-case basis to determine an future acquisition strategy.

11. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Beverly Miller Date Administrative Specialist Lebanon VAMC

12. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Keri Hester Date Contracting Officer Commodities 2, NCO 4

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

William DeQuinzio Date Branch Chief

Commodities 2, NCO 4

BEVERLY MILLER Digitally signed by BEVERLY MILLER Date: 2025.09.03 16:00:57 -04'00'

Keri Hester Digitally signed by Keri Hester Date: 2025.09.03 16:07:13 -04'00'

WILLIAM DEQUINZIO

Digitally signed by WILLIAM

DEQUINZIO

Date: 2025.09.03 17:07:46 -04'00'