6515--TSA Shoulder Instrument Set (VA-26-00014278)

Form / Attachment / Pricing Sheet

This document is the "Buy American Certificate" provision (FAR 52.225-2, Oct 2022). It requires offerors to certify the domestic content of end products and critical components proposed for the opportunity.

• Certification: Offerors must certify that each end product is a domestic end product and that domestic end products contain a critical component, unless listed otherwise.
• Foreign End Products: A table is provided to list foreign end products, their country of origin, and whether they exceed 55% domestic content.
• Domestic End Products with Critical Components: A section to list line item numbers of domestic end products containing a critical component.
• Definitions: Key terms such as "commercially available off-the-shelf (COTS) item," "critical component," "domestic end product," and "foreign end product" are defined within the context of the "Buy American-Supplies" clause.

Bidders must complete and submit this certificate as part of their proposal. It is crucial for determining compliance with Buy American Act requirements, which can impact offer evaluation as per FAR Part 25.

Form / Attachment / Pricing Sheet

This document, "Attachment A: Comprehensive Parts List," details the specific components and quantities included in various "FA S ALT" surgical kits. These kits appear to be related to orthopedic procedures, specifically shoulder and hip surgeries, and include components for "Anatomic CS Edge," "Anatomic Glenoid," "Anatomic Humeral Head," "Anatomic Humeral Stem," "AltiVate Reverse Glenoid," "AltiVate Reverse Humeral Preparation," and "AltiVate Reverse Humeral Trialing." The list includes part numbers, descriptions, and quantities for each item within each kit.

• FA S ALT ANATOMIC CS EDGE: Comprehensive list of parts for a hip/anatomic CS edge system.
• FA S ALT ANATOMIC GLENOID: Detailed components for an anatomic glenoid system.
• FA S ALT ANATOMIC HUM HEAD: Parts list for an anatomic humeral head system.
• FA S ALT ANATOMIC HUM STEM: Components for an anatomic humeral stem system.
• FA S ALTIVATE REVERSE GLENOID: Parts for an AltiVate Reverse Glenoid system.
• FA S ALTIVATE RSP HUM PREP: Instruments for AltiVate Reverse Humeral Preparation.
• FA S ALTIVATE RSP HUM TRLS / SML: Components for AltiVate Reverse Humeral Trialing (standard and small).
• Additional Items: Includes specific retractors, protectors, handles, and drill guides.

This attachment is crucial for bidders to understand the exact components and quantities required for the surgical kits associated with this opportunity. It will inform procurement strategies, inventory management, and potentially pricing if the opportunity involves supplying these specific parts or kits. Bidders must ensure they can source or provide these exact items as specified.

Statement of Work (SOW) / Performance Work Statement (PWS)

To deliver Enovis TSA Shoulder Instrument Sets to the VA Eastern Colorado Health Care System.

• Deliver all items listed in section 2.5, meeting all salient characteristics defined therein.

• Ensure installation meets manufacturer specifications.

• Provide detailed item specifications, including the Enovis TSA Shoulder Instrument Sets or brand name or equivalent (refer to Solicitation and Attachment A for a full breakdown).

• Delivery Timeframe: Within 30 days of award, unless otherwise specified.

• Delivery Location: VA Eastern Colorado Health Care System, 1700 N. Wheeling Street, Aurora, CO 80045.

• Delivery Markings: Items must be in manufacturer's original sealed containers, marked with the manufacturer's name, PO, and contract number.

• Delivery and installation coordination will be through the On-Site Point of Contact (POC).

• Provide two (2) binders and one (1) digital copy of all manufacturer recommended maintenance schedules and operation materials upon completion of installation.

• Provide all manufacturer(s) warranties for parts and labor at the time of delivery.

• Warranties must include all travel and shipping costs for any warranty repair.

• Security background checks are not required.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation (RFQ #: 36C25926Q0214) for a Total Shoulder Arthroplasty Instrument Set for the Department of Veterans Affairs, Eastern Colorado VA Healthcare System in Aurora, CO. The government anticipates awarding a firm-fixed-price contract. This announcement constitutes the only solicitation, and a separate written solicitation will not be issued.

• The primary requirement is for a Total Shoulder Arthroplasty Instrument Set. Specific items are listed as "Brand Name or Equivalent" and reference the Enovis FAS product line. Refer to the attached Statement of Work (SOW) and Attachment A for detailed specifications.

• This is a Brand Name or Equal requirement.

• Contract Type: Firm-fixed-price.

• Delivery and Acceptance: F.O.B. Destination to Rocky Mountain Regional VAMC, Aurora, CO 80045.

• Questions Deadline: February 11, 2026, 12:00 PM MT. All questions must be submitted in writing.

• Quote Submission Deadline: February 13, 2026, 4:00 PM MT.

• Submission Method: Emailed quotes only (4MB email limit). Faxed or hand-carried quotes will not be accepted.

• Evaluation Factors:

  1. Technical capability or quality offered to meet the Government requirement.
  2. Price.

• Offers will be evaluated based on comparative analysis. Offers not meeting the technical capability will not be selected regardless of price.

• Award will be made on an All or Nothing Basis.

• This solicitation is Unrestricted with No Set-Aside.

• NAICS Code: 339112 (Business size standard: 1,000 Employees).

• The solicitation document incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-06.

• Offerors must complete and submit required volumes: Technical Capability, Price, and FAR 25 Provision (e.g., Buy American Certificate).

• Refer to attached documents: P09_SOW_Envois TSA Shoulder Set, Attachment A, and FAR 52.225-2 Buy American Certificate.