JUSTIFICATION_Redacted.pdf

Effective Date: 12/30/2025 Page 2 of 4 Revision: 02 Acquisition ID#:

480000100 DePuy Synthes Instrument Case Base 4

451570232 VELYS™ Instrument Tray - Knee 4

129901054 CAS Balancer Set 4

129901055 CAS Tensor Space 5MM 8

129901056 CAS Tensor Space 10MM 8

129901080 CAS Ligament Tensor Size 2-XF 4

129901081 CAS Ligament Tensor Size 4-XF 4

4. Statutory Authority Permitting Restricted Competition:

RFO FAR 12.201-1 Simplified Procedures. The statutory authority for applying the Simplified Procedures is 41 U.S.C. § 1901 and is implemented by FAR 12.102(b) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(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): A system allowing robotic surgical support during orthopedic surgeries is needed and only the VELYS system is compatible with the existing Attune Knee system which is currently utilized by facility staff in the performance of orthopedic knee replacements. The VELYS Robotic-Assisted Solution is designed to enhance surgical precision by integrating CT-free technology to optimize implant placement.

This system equips surgeons with the information needed to preserve the soft tissue envelope, predict joint stability, and work towards returning knee function. VELYS captures intra-op bony landmarks and gives real-time insights with CT-free technology to create a personalized plan for each surgery. VELYS Robotic-Assisted Solution is designed to increase the accuracy of implant alignment and works exclusively with the ATTUNE Knee System which can shorten Veteran recovery and reduce post-operative complications. The VELYS system is also known for a reduced footprint versus other knee robotic systems. While published pricing could not be located to consider the investment made to date with the ATTUNE Knee System, purchase order 36C24623P0939 was located and referenced a price of $662,776.96 for ATTUNE Knee System instruments in 2023, so the system itself is believed to have been a significant investment. Repurchase of another Knee System to allow for further robotic solutions would likely represent Government waste.

Effective Date: 12/30/2025 Page 3 of 4

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6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: As only DePuy Synthes Sales Inc can provide the necessary equipment, no other sources can be considered. This requirement will be synopsized with a notice of intent to sole source to DePuy posted at the Government Point of Entry (SAM.gov). The Justification and Approval will be publicized as well as an award notice.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated prices will be compared to previous contracts awarded for the VELYS Surgical Robot System to determine price fair and reasonable before award.

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

Statement of the Reasons Market Research Was Not Conducted: SAM.gov and VA ADDS UP were searched to identify prior awards for VELYS. Both searches resulted in awards only to DePuy Synthes Sales, Inc, a subsidiary of Johnson & Johnson Health Care Systems Inc.

A google search confirmed that DePuy /Johnson & Johnson is the manufacturer of the Attune Knee system which the station requires compatibility with as a part of this requirement. A market research inquiry to DePuy on 3/6/2026 received a response confirming that the VELYS robotic system is the only compatible robot for the Attune Knee and confirmed that only DePuy sells the VELYS system as there are no authorized distributors. OEM also confirmed Country of Origin as USA making the VELYS system a domestic end product.

A Small Business Administration (SBA) Small Business Search yielded 409 Service Disable Veteran Owned Small Businesses (SDVOSBs) or Veteran Owned Small Businesses (VOSBs) in the Surgical and Medical Instrument Manufacuturing space but given that there is no authorized distribution for the specific devices necessary, none of these SDVOSBs or VOSBs would be capable of meeting the requirement.

With only one vendor authorized to sell the VELYS Robotic System and no other compatible surgical robots on the market, this shall be a sole source to DePuy Synthes Sales Inc. No existing contracts were found during market research so this will be an open market procurement. The rule of two cannot be met. The Non- Manufacturer Rule will not apply as no set aside can be held.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

There are no other facts.

10.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

DePuy Synthes Sales, Inc, Large Business, CDVHC3LBW5X8

Effective Date: 12/30/2025 Page 4 of 4

Acquisition ID#:

11.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: No other vendor is able to provide the VA Southern Nevada Healthcare System (VASNHCS) Las Vegas with a robotic system capable of integrating with the existing ATTUNE Knee System. Market research will continue to be conducted for future requirements, seeking opportunities for competitive procurements.

12.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.

13.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.

b. One Level Above the Contracting Officer : I certify the justification meets requirements for other than full and open competition.