Disc Replacement and Lumbar Fusion Implants

Notice of Intent to Sole Source The Naval Medical Center San Diego (NMCSD) intends to award a sole source purchase order under the authority of FAR 13.106-1(b), due to only one source being available to meet the Government's needs, to the Depuy Synthes Sales Inc., 1302 Wrights Ln E, West Chester, PA 19380-3417. Requirement is anterior lumbar interbody fusion product and lumbar disc arthroplasty product for the L4-5 ALIF and L5-S1 arthroplasty procedures. The required implants are patient specific. The instrumentation must meet the following salient characteristics: 1) Comprehensive compliance program for the procedures, 2) Four-way retracting frame protecting patient's key vessels and hold patient's anatomy away from the site of operation, 3) Implants must be a PEEK implant to support bone growth, 4) Stand-alone without back-up posterior lumbar rods and screws, 5) Must prevent back-out by utilizing titanium screws that lock into a titanium faceplate. Date of surgery is 23 January 2017. Depuy Synthes is the only manufacturer that meets all the requirements and can provide the salient characteristics. They are California compliant with comprehensive compliance program. Their implants are made from PEEK material that is most similar to cortical bone. Depuy Synthes provides a four quadrant retractor that allows for optimal visualization for any patient anatomy as well as protection from major vessels i.e. the aorta from being ruptured. Also this company provides a stand-alone cage with 4 screws that is equivalent to a spacer with pedicle screws and allows for less surgical time and a less invasive procedure as only one incision site. Their faceplate and screws are made of titanium due to the human body's acceptance to the metal. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work. Capability statements shall not exceed 5 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order. Capability statements are due by 10:00 AM Local Time, January 18, 2017. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: contact@example.gov.