6515--Aspen Total Joint Program (Brand Name or Equal to) 36C24426Q0405

Aspen Surgical Symmetry Orthopedic Instruments Brand Name or Equal Background: The Department of Veterans Affairs, Erie, PA VA Medical Center, Surgical department is implementing a Total Joint Initiative to expand and sustain its ability to perform shoulder, knee, and hip surgeries in house. This initiative supports the delivery of comprehensive orthopedic care, improves access for Veterans, and reduces reliance on community care. As part of this initiative, the Erie, PA VA Medical Center has already invested in standardized surgical platforms and equipment, including powered surgical instruments, to ensure consistency, interoperability, and operational readiness within the Surgery department. These investments were made to establish a reliable, system-based approach to Total Joint replacement procedures. To fully support the Total Joint Initiative, our Surgery department requires the acquisition of reusable orthopedic surgical instruments necessary to assemble standardized instrument trays for use during shoulder, knee, and hip total joint procedures. These instruments must be suitable for repeated use in a high-volume surgical environment and compatible with existing VA sterilization and operating room procedures. Scope of Work: The Erie, PA VA Medical Center requires the procurement of brand name or equal to Aspen Surgical Symmetry orthopedic instruments to support our newly established Total Joint Initiative. The instruments shall be suitable for inclusion in standardized orthopedic instrument trays and must be compatible with existing operating room workflows, sterilization methods, and clinical practices at the Erie, PA VA Medical Center. Brand name requirement (Brand Name or Equal): Aspen Surgical Symmetry Orthopedic Instruments # Part # Description Qty 1 32-3423 Symmetry Hook; Bone; Sharp; Heavy Duty; 19 mm Diameter; 9 in; 228 mm 4 2 28-9406 Symmetry Osteotome; Lambotte; Straight; 1/4 in; 9 in; 228 mm 4 3 28-9420 Symmetry Osteotome; Lambotte; Straight; 3/4 in; 9 in; 228 mm 4 4 28-9425 Symmetry Osteotome; Lambotte; Straight; 1 in; 9 in; 228 mm 4 5 28-9430 Symmetry Osteotome; Lambotte; Straight; 1 1/4 in; 9 in; 228 mm 4 6 28-9440 Symmetry Osteotome; Lambotte; Straight; 1 1/2 in; 9 in; 228 mm 4 7 28-9456 Symmetry Osteotome; Lambotte; Curved; 1/4 in; 9 in; 228 mm 4 8 28-9462 Symmetry Osteotome; Lambotte; Curved; 1/2 in; 9 in; 228 mm 4 9 28-9470 Symmetry Osteotome; Lambotte; Curved; 3/4 in; 9 in; 228 mm 4 10 28-9475 Symmetry Osteotome; Lambotte; Curved; 1 in; 9 in; 228 mm 4 11 28-9480 Symmetry Osteotome; Lambotte; Curved; 1 1/4 in; 9 in; 228 mm 4 12 28-9490 Symmetry Osteotome; Lambotte; Curved; 1 1/2 in; 9 in; 228 mm 4 13 65-2512 Symmetry Elevator; Key; 1/2 in Blade Width; 7 1/2 in; 190 mm 4 14 65-2513 Symmetry Elevator; Key; 3/4 in Blade Width; 7 1/2 in; 190 mm 4 15 55-7025 Symmetry Elevator; Freer; Sharp/Blunt; 4.5 mm Width; Double-Ended; 7 1/2 in; 190 mm 4 16 77-1168 Symmetry Retractor; Hohmann; 22 mm Wide 4 17 77-1118 Symmetry Retractor; Hohmann; 18 mm Wide; w/Finger Ring; 9 1/2 in 4 18 30-4088 Symmetry Forceps; Lahey Goitre Tenaculum; 6 1/4 in 8 19 29-8819A Symmetry Curette; Cobb; Angled; Size 00; w/Round Handle; 11 in; 279 mm 4 20 29-8820A Symmetry Curette; Cobb; Angled; Size 0; w/Round Handle; 11 in; 279 mm 4 21 29-8821A Symmetry Curette; Cobb; Angled; Size 1; w/Round Handle; 11 in; 279 mm 4 22 29-8824A Symmetry Curette; Cobb; Angled; Round Handle; Size 4; 11 in; 279 mm 4 23 46-3028 Symmetry Driver; Cervical Graft; Unguarded 4 24 31-5105 Symmetry Rongeur; Leksell; 5 mm; Slightly Curved Handle; 9 in; 228 mm 4 25 65-2546 Symmetry Elevator; Cobb Spinal; 1/2 in Blade Width; 11 in; 279 mm 4 26 65-2547 Symmetry Elevator; Cobb Spinal; 3/4 in Blade Width; 11 in; 279 mm 4 27 28-7030 Symmetry Osteotome; Cobb; Curved; 5/8 In Wide; 11 in 4 28 46-2011 Symmetry Osteotome; Curved; 3/8 4 29 46-2506 Symmetry Osteotome; Smith-Peterson; Straight; 1 1/4 in 4 30 27-0401 Symmetry Mallet; 1 1/2 in Head; 2 lbs. Weight; 7 1/2 in; 190 mm 4 Salient Characteristics: The following salient characteristics for the orthopedic surgical instruments must meet all of the following to be considered technically acceptable. These characteristics represent the minimum needs of the Erie, PA VA Medical Center s Total Joint Program and are required to support shoulder, knee, and hip joint replacement procedures. Functional Equivalence Instruments must be functionally equivalent to the reference brand name items and capable of performing the same surgical tasks in shoulder, knee, and hip total joint procedures. The instruments must be appropriate for: bone cutting and resection bone manipulation and exposure retraction and tissue handling malleating and impaction Dimensional and Design Equivalence Instruments must be dimensionally comparable to the referenced items including: Comparable blade widths, lengths, and curvatures Comparable working end geometry Minor dimensional variations are acceptable provided they do not affect surgical function or tray compatibility. Materials and Construction Instruments must be constructed of surgical grade materials, such as stainless steel, suitable for orthopedic surgical use. Construction must support repeated use in a high-volume surgical environment. Instruments must be free of manufacturing defects and finished to standards appropriate for surgical instrumentation. These instruments must be intended for reusable surgical use and comply with all applicable FDA, AAMI, and VA standards. AAMI ST79 AAMI ST81 Sterile Processing and Reprocessing Compatibility Instruments must be compatible with existing Erie, PA VAMC, Sterile Processing Services (SPS) workflows. Instruments must be compatible with moist heat (steam) sterilization, which is the standard sterilization method used by the Erie, PA VAMC. Instruments must be capable of being: Manually cleaned Ultrasonically cleaned Processed in automated washer and disinfectors Suitable for use in wrapped trays or rigid containers Instrument design must allow effective cleaning of hinges, joints, crevices, and working surfaces. Security & Privacy: The vendor will not be on station therefore the Certification & Accreditation (C&A) requirements of VHA Handbook 6500.6 do not apply to this requirement; therefore, a Security Accreditation package is not required. No C&A or MOU/ISA is required. Sensitive information exposure as part of this contract involves applicable security controls within the facility as part of the VA Information Security Program. If there are any questions related to privacy, please have a member of your staff contact the VA Privacy Service at 202-461-6309. If there are any questions related to information security, please have a member of your staff contact the Office of Cyber Security at 304-262-7733. Delivery: All items must be FOB Destination, 30 Days ARO, to the following location: Erie VA Medical Center Attn: Distribution Center 135 E. 38th Street Erie, PA 16504 Monday Friday from 8:00am 4:00pm

End of Document