S02 JOFOC_Redacted.pdf

Request for Sole Source Justification Format >SAT 36C25026AP4033 – ROSA Recon Platform

VHAPG Part 806.3 OFOC Page 1 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C25026AP4033

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office

10 (NCO 10), located at 24 Frank Lloyd Wright Drive, Lobby M, Suite 2200, Ann Arbor, Michigan 48105 in support of VISN 10, Dayton VA Medical Center (VAMC) at 4100 W. Third St, Dayton, OH 45428. The purchase request (2237) number for this acquisition effort is 552-26-3-121-0102.

2. Nature and/or Description of the Action Being Approved: NCO 10 proposes to award a new Firm-Fixed-Price order to Zimmer Biomet, Unique Entity ID (UEI) U9BBMTXTPXY8, or an authorized offeror providing the product of the approved source, for ROSA Knee System items using Department of Veterans Affairs funds.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The Dayton VAMC has a requirement for one each ROSA Recon Platform 110V (P/N 20802010001), the core for the ROSA Knee System, an FDA-cleared robotic surgical assistant designed to help orthopedic surgeons perform total knee replacements with high precision which includes one ROSA Robotic Unit Cover (or Drape) (P/N 20802008002). The Dayton VAMC also requires four sets of the ROSA Knee General Instrument Kit (ROSAGEN) (P/N KT802005000), a specialized surgical tray system used with the ROSA Knee System; four sets of the ROSA Knee Persona V1.4 Kit (ROSAPSN4) (P/N KT802006004), a specialized surgical instrument set; and one each ROSA Patient-Specific Instrument (PSI) X-ray Calibration Object (P/N 20808502000). The total estimated value is $ 736,083.00.

Line Item Part Item Qty Unit Unit Price Amount

1 20802010001 Rosa Recon Platform 110V 1 Ea .00 2 20802008002 ROSA ROBOTIC UNIT COVER 1 Ea

3 KT802005000 ROSA KNEE GENERAL INSTR

KIT (ROSAGEN) 4 Ea $

4 KT802006004 ROSA KNEE PERSONA V1.4

KIT (ROSAPSN4) 4 Ea $

5 20808502000 PSI X-RAY CALIBRATION OBJ 1 Ea

VHAPG Part 806.3 OFOC Page 2 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033

4. Statutory Authority Permitting Other than Full and Open Competition: The statutory authority permitting other than full and open competition for this effort is:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will

Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Strenuous military training, carrying heavy physical loads, repetitive impacts, and acute trauma causing service-related joint injuries frequently lead to early-onset osteoarthritis for veterans, making partial or total knee replacement a frequently performed procedure within the U.S. Department of Veterans Affairs (VA) health system.

The Zimmer Biomet ROSA Knee System contains Tri-modal imaging on one platform. The ROSA system is the only major system that allows the surgeon to choose CT-based, plain-film X-ray-based, or fully imageless planning within a single platform. This adds the flexibility to match the imaging approach to case complexity, cost, and patient radiation-exposure considerations instead of mandating one approach over another.

The ROSA system preserves full surgeon control without the haptic resistance of other systems; it positions a cutting jig/guide and lets the surgeon complete the resection with a standard oscillating saw.

The ROSA Recon Platform provides live, dynamic kinematic joint mapping, capturing how the knee moves through space in real time via infrared optical tracking. This distinct feature lets surgeons assess ligament tension and rotational alignment dynamically rather than from static, pre-operative measurements alone.

Use of the ROSA Platform reduces pin-site trauma and instrumentation setup time as the ROSA uses motion-sensitive tracking that allows accurate bone resection

VHAPG Part 806.3 OFOC Page 3 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033 without rigidly pinning the cutting guide to the bone unlike other systems that rely on bone-pinned optical trackers or a fixed robotic arm reference.

The Dayton VAMC existing surgical staff are trained and certified on the ROSA ecosystem; this familiarity allows for a faster operation providing an improved surgeon and patient experience. Additionally, the ROSA system is better suited to train residents because it keeps the saw in the hand of the surgeon as they learn surgical techniques.

The ROSA Knee System is more cost effective as the average cost is $681,150.00 with an over the life of the system total cost of $3,405,752.00 compared to the average cost of $829,877.00 for the Stryker MAKO system with a total life cost of $15,767,657.00.

Accordingly, Zimmer Biomet, Unique Entity ID (UEI) U9BBMTXTPXY8, or an authorized offeror only are capable of providing the supplies and services described in Section III above without the Government experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies):

Sources Sought Notice 36C25026Q0873 was posted to Contract Opportunities section of SAM.gov on August 13, 2026, with a response due date of Noon 12:00 PM (EST) on Thursday, August 20, 2026. Red One Medical Devices LLC, which has been identified as the exclusive federal distribution and contracting partner for Zimmer Biomet responded. The company BHPE LLC also responded but only stated, “This communication expresses BHPE LLC's keen interest in participating as an interested vendor.” BHPE LLC did not provide any information as to whether it sought to provide the requested product or a similar product. When asked via email to provide BHPE LLC's capability to fulfil this requirement, the company did not respond. There was no other interest expressed concerning this acquisition effort or the acquisition strategy.

On 8/27/2026 Sources Sought Notice 36C25026Q0873 was reopened within the Contract Opportunities section of SAM.gov with a new response due date of 8:00 AM (EST) on Tuesday, September 8, 2026. This second notification received an identical email from BHPE LLC expressing its “keen interest in participating as an interested vendor” but still without information about how it would or if it could fulfil the current requirement by providing the requested product or a similar product.

Small business concern Mojo Solutions and Services (MSS) LLC also sent an email in response to the reopened Sources Sought Notice. The response from MSS

VHAPG Part 806.3 OFOC Page 4 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033 included Past Performance Record and Capability Statement data sheets. Neither of which contained the words “robotic” or “robot” but did convey the company has OEM & Distribution Partnerships with both Medline Industries and Henry Schein for medical/surgical, dental, laboratory, etc. equipment. MSS also asserted “we can furnish ROSA Recon platforms, new equipment only, delivered F.O.B. destination, with full manufacturer warranty and authorised-distributor [sic] traceability.” MSS did not offer to supply an alternative system to the foreign-made ROSA system.

Although MSS was established in 2011, searches within SAM.gov and USASpending.gov reveal MSS does not have any award actions with the US Government, as of this date, compared to over 9000 for Red One Medical Devices and over one hundred for BHPE making its viability as a source for this effort questionable.

Additionally, the solicitation will be posted to, and publicly available in, the Contract Opportunities section of SAM.gov.

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

Fair and Reasonable: I hereby determine the anticipated cost to the Government for this contract action will be fair and reasonable. This determination will be based on the results of price analysis and review of data other than certified cost or pricing data. The contractor will not be the contractor will not be required to submit certified cost or pricing data as this requirement has been determined to be for commercial products; the contractor may be requested to submit other than certified cost and pricing data, if other forms of evaluation are exhausted.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research completed in August 2026 included queries within the AbilityOne Procurement List, the General Services Administration’s (GSA) Advantage and eLibrary websites, the System for Award Management (SAM) site, the National Acquisition Center (NAC) MedSurg Catalog, and the VA Supply Chain Master Catalog (SCMC). The research found no established enterprise contracts that meet the requirements of the current acquisition effort. Although there are small business concerns that include NAICS code 334510 in their profiles, small business concern Red One Medical Devices LLC was discovered as the exclusive federal distribution and contracting partner for Zimmer Biomet, Red One Medical Devices LLC (UEI:

C2WBTZ9TQDG9). For this reason, neither the VA Rule of Two nor the SBA Rule of Two can be met.

Neither term “knee system” or “surgery robot” returned any records within the searched AbilityOne Procurement List. GSA Advantage was searched for keyword phrases: “knee system” and “surgery robot” and although each returned results, none appeared to be for a robotic surgery assistant or associated items. The GSA

VHAPG Part 806.3 OFOC Page 5 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033 eLibrary search of “knee system” and “surgery robot” did not provide any information on robotic surgery assistants as the results were for orthopedic/surgery supports;

industrial products and services – hardware and tools; and furniture & furnishing – fitness solution. Searched combinations of NAICS code 334510, PSC 6515, “knee system,” “surgery robot,” and the socio-economic statuses of VOSB and SDVOSB in the Contract Awards section of SAM.gov but this did not provide a good idea of who has sold the ROSA Recon Platform to the Government. However, searching “knee system” and ROSA did provide four results: the exclusive distributor Red One Medical Devices LLC and the manufacturers’ US entity, Zimmer US. The SBA Small Business Search database was searched. There are 2,636 small businesses with NAICS code 334510 in their profile. There are 599 small business concerns where the NAICS code is its primary NAICS code. However, none of these companies include the keyword phrases “knee system” or “surgery robot” in its profile. A more nuanced search within the NAC’s MedSurg Catalog was conducted. “Knee system” provided results but none appeared to be for the likes of the current requirement.

“Surgery robot” yielded no active items. Search of “ROSA” provided results, but none were for robotic surgery assistants. This was further seen when Red One Medical Devices LLC, the exclusive small business contractor for the Zimmer Biomet’s ROSA System, was searched and no results were found. Likewise, a search of “Zimmer Biomet” produced no results. The search in SCMC revealed no contracts for the current requirement.

Between 8/7/2026 amd 8/10/2026, research in Google provided the following in regard to comparable orthopedic robotic systems:

The country of origin for the Stryker Mako System is the United States. It is manufactured by Stryker Corporation headquartered in Portage, Michigan. The Mako System requires a pre-operative CT scan and uses a physical haptic robotic arm, giving it a rigid workflow with high radiation and imaging overhead (costs). The ROSA system avoids mandatory CT scans by accepting simpler X-ray or image-free data.

The country of origin for the CORI Surgical System, manufactured by Smith & Nephew, is the United Kingdom. Although this system primarily utilizes imageless solutions, the CORI uses a handheld smart burr while the ROSA system gives surgeons the choice of data input formats without forcing a handheld milling style.

The country of origin for the VELYS Robotic-Assisted Solution is Ireland. The legal manufacturer is DePuy Ireland Unlimited Company while DePuy Synthes, part of Johnson & Johnson MedTech, is the parent organization, headquartered in the United States. This system also utilizes imageless solutions, but the VELYS mounts to the bedrail to guide an oscillating saw while, again, the ROSA system gives surgeons the choice of data input formats and avoids the handheld milling style.

Although parent company Corin Group is based in the United Kingdom, the country of origin for the OMNIBotics system is the United States. The system focuses

VHAPG Part 806.3 OFOC Page 6 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033 heavily on ligament tensioning via specific ligament balancers, whereas the ROSA system integrates data-driven soft tissue evaluation directly into a streamlined, traditional jig-based cut.

NAICS code 334510 appears in the Non-Manufacturer Rule Class Waiver Database, dated June 2022. The class waiver for NAICS code 334510 was posted to the Federal Register 12/20/2007 in Federal Register Notice 72 Fed. Reg. 72433.

The ROSA Knee System items of this request are manufactured by Zimmer Biomet in the UNITED STATES, FRANCE, CANADA, and SWITZERLAND. An Individual Nonavailability Waiver Determination is expected to be completed prior to soliciting.

As described in Section 6 above, in accordance with RFO Part 10, Sources Sought Notice 36C25026Q0873 was posted to Contract Opportunities section of SAM.gov on August 13, 2026, with a response due date of Noon 12:00 PM (EST) on Thursday, August 20, 2026. Only two companies expressed interest with only one having a demonstrated capability to fulfil the current requirement. The reopened Sources Sought Notice posted August 27, 2026, with responses due by 8:00 AM (EST) on Tuesday, September 8, 2026, elicited the attention of a third concern which indicated it could “furnish ROSA Recon platforms”. However, further investigation makes it doubtful this third concern would actually provide a quote.

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

None.

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

Three companies have expressed interest in this acquisition effort, the first is Red One Medical Devices LLC (UEI: C2WBTZ9TQDG9), a small business and the exclusive federal distribution and contracting partner for Zimmer Biomet. The second company is BHPE LLC (UEI: UPDJHPJUYQ71), a Service-Disabled Veteran-Owned Small Business (SDVOSB) concern, which expressed a keen interest in participating as an interested vendor but did not provide its capability to do so as requested by the Sources Sought Notice posted to SAM.gov. The third company is small business Mojo Solutions and Services (MSS) LLC (UEI:

KA5MY6SKBYL8), which states it too can provide the ROSA platform, but the company has yet to receive an award action from a federal agency since its establishment in 2011.

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: The Government will continue to monitor the market and conduct market research to identify potential sources for future

VHAPG Part 806.3 OFOC Page 7 of 7 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C25026AP4033 similar requirements, including any new vendors or solutions that may become compatible with the current infrastructure.

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.

Christopher S. Ahn Date Supervisory Biomedical Engineer Dayton VA Medical Center

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

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

Rachell J. Hamer Date Contracting Officer Network Contracting Office (NCO) 10

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Date Branch Chief – Services Supply Prosthetics Team 5 Network Contracting Office (NCO) 10

CHRISTOPHER AHN Digitally signed by CHRISTOPHER AHN Date: 2026.09.09 10:02:30 -04'00'

RACHELLE HAMER Digitally signed by RACHELLE HAMER Date: 2026.09.09 10:05:26 -04'00'

ADAM WEBER

Digitally signed by ADAM

WEBER

Date: 2026.09.09 10:09:14 -04'00'