Lumbar Fusion Implant with Anterior Plate and Posterior Pedicle Screws

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 Depuy Synthes Sales Inc. 325 Paramount Dr. Raynham, MA, 02767-5199 Requirement is Anterior Lumbar Interbody Fusion with Anterior Plate and Posterior Pedicle Screws for L4/5 ALIF and PERC Fixation procedures. The required implants are patient specific. 1) The implant for the posterior percutaneous must meet the following salient characteristics: a) Meet California compliance b) Favored angle screw head c) Feature cannulated screw shanks d) In-line nature of anchor e) Cannulated pedicle screws 2) The implant for the anterior lumbar interbody fusion must meet the following salient characteristics: a) Have a comprehensive compliance program for the procedure b) Provide a four way retracting frame that protects patient's key vessels as well as hold the patient's anatomy away from the field of view and site of operation c) Provide a PEEK implant that is most similar to cortical bone to support bone growth d) Have titanium screws that lock in to a titanium faceplate preventing back-out. Date of Surgery is 30 January 2017 Depuy Synthes is the only manufacturer that meets all the requirements for Neurosurgery and that can provide these 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 the 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 09:00 AM Local Time, January 24, 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.