LSJ_Aesculap Anteriror Lumbar Interbody Fusion (ALIF) system_Final_Redacted.pdf

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

Justification and Approval for Other than Full and Open Competition

Limited Sources Justification for Brand Name Acquisition

1. Identification of the agency and contracting activity: Defense Health Agency (DHA), Enterprise Medical Support - Contracting Division (EMS-CD), Joint Base San-Antonio, TX 78234.

2. Nature and/or Description of Action being approved: The EMS-CD requests approval to award a sole source contract for the purchase of two (2) sets of Aesculap Anterior Lumbar Interbody Fusion (ALIF) systems.

3. Description of Supplies/Services: The Government has a need for the purchase of two Anterior Lumbar Interbody Fusion (ALIF) systems. The ALIF systems that will be utilized for upcoming spinal implant surgeries that will take place at the NMRTC San Diego. Based on the anatomy of the patient(s) being treated the ALIF system must include the following capabilities:

Endplate design that does not require keel cut for implementation.

Synthetic disc for the lumbar spine Multiple different sized footprints to best fit the patient’s anatomy Multiple angles of lordosis for best fit to patient’s anatomy Multiple heights to choose from for best fit to patient’s anatomy Compatibility with existing instrumentation available within the hospital

Estimated Value:

Delivery Date(s): 1 April 2024

Proposed Contract Type: Firm Fixed Price (FFP)

Funding Type: Defense Health Program (DHP)

4. Statutory Authority Cited permitting other than full and open competition: 41 U.S.C. 1901; as implemented at Federal Acquisition Regulation (FAR) 13.106-1(b)(1), soliciting from a single source for purchases not exceeding the simplified acquisition threshold.

5. Rationale Justifying Use of the Statutory Authority Cited: The Aesculep, Inc. activL Active Disc Anterior Lumbar Interbody Fusion (ALIF) spinal implant systems are the only commercial market ALIF system that meets the Government’s requirements based on the anatomy of the patient being treated and the required compatibility with existing instrumentation available within the hospital. Market research identified that there are 3 commercial manufacturers that make artificial lumbar discs:

, and Aesculap ActiveL. Aesculap is the only company that offers an ALIF with an endplate design that does not require keel cut for implementation.

Aesculap, Inc. is the Original Equipment Manufacturer (OEM) for the activeL Artificial Disc ALIF systems.

Due to the proprietary rights, Aesculap, Inc. is the manufacturer and distributor of the activeL Artificial Disc systems. The system or parts of the system are not sold and/or distributed by any other commercial entity.

6. Efforts to Obtain Competition: Due to the proprietary rights, Aesculap, Inc. is only source capable of providing the required equipment. There are no opportunities to obtain additional competition for this specific brand name product.

FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable: Prior to award, the contracting officer will determine that the proposed price for the required equipment is fair and reasonable. In accordance with FAR 13.106-3(a)(2) in acquisitions, the contracting officer may base the statement of price reasonableness on competition; market research; comparison of the proposed price with prices found reasonable on previous purchases; current price lists, catalogs, or advertisements; a comparison with similar items in a related industry; contracting officer’s personal knowledge of the item being purchased; comparison to an independent Government estimate; or any other reasonable basis.

8. Market Research: Market research did not identify any alternative Anterior Lumbar Interbody Fusion (ALIF) systems capable of meeting the Government’s needs. Market research identified that there are 3 commercial manufacturers that make artificial lumbar discs: , , and Aesculap ActiveL. Aesculap is the only company that offers an ALIF with an endplate design that does not require keel cut for implementation.

The Government’s market research efforts included: a query of Government, scientific, and/or business search engines; a review of catalog of ; meetings/discussions with other Government offices and/or industry; a review of the General Services Administration (GSA) catalog. The notices required by FAR 5.202 will be posted.

9. Other Facts: N/A

10. Interested Sources: To date, no sources have expressed interest in this requirement.

11. Actions to overcome barriers:

(a) Efforts to Obtain Competition: Efforts to obtain competition are limited due to the OEM’s proprietary rights.

(b) Actions to Increase Competition: Actions to increase competition are limited due to the OEM’s proprietary rights.

(c) Follow-on Order: The Government will continue to conduct market research in support of future requirements.