Total Orthopaedic Solutions 4

Products and services used in Orthopaedic, Trauma and Spine procedures, including medical devices (including Orthopaedic specific equipment such as power tools), equipment management services and orthopaedic specific services.

Note: For future tenders the following requirements will apply:

• ISO Certification: Tenderers must have ISO 9001: 2015 or BS EN ISO 13485:2016 or Medical Device Single Audit Program (MDAP) accredited by the United Kingdom Accreditation Service (or international equivalent) to cover all segments of the Tenderer’s and the product’s supply chain. This should include, but not be limited to, sales, manufacturing, storage and distribution ('ISO Certification'). Link for acceptable UKAS alternatives https://iaf.nu/en/accreditation-bodies/ (‘Notified Bodies’).
• CE Certification and Declaration of Conformity certificates are required where applicable to be presented at submission stage of the tender.
• Modern Slavery for Tenderers that have an annual turnover of at least £36 million must have a link to their modern slavery statement on their website.
• Modern Slavery Assessment Tool (MSAT) Tenderers must have a score of 41% or above within 12months of the Tender Publication Date via https://supplierregistration.cabinetoffice.gov.uk/
• Evergreen Sustainable Supplier Assessment – Tenderers will need to have completed the assessment and achieved Level 1 within the 12 months prior to the Tender Close Date. Link for instructions and access for this assessment: https://www.england.nhs.uk/nhs-commercial/central-commercial-function-ccf/evergreen/
• Carbon Reduction Plan (CRP): Tenders must have a valid CRP link on their website that meets the requirements of PPN 006 as outlined in the PPN, OR Where Supplier has no website, the CRP is provided in PDF format that meets the requirements of PPN 006 as outlined in the PPN, OR Excused in exceptional circumstances.
• Cyber Security: If you handle patient or personal data, or provide any IT systems, services, or devices you will need to have a Cyber Security Essentials Plus Certificate.

This Lot includes thirteen Lot categories.

• 1.1: Orthopaedic Primary and Hemiarthroplasty Hips: Primary total hip replacement and hemiarthroplasty, instruments required for supporting supplier implant products within this Lot category.
• 1.2: Orthopaedic Primary and Partial Knees: Primary Knee replacement including total knee and partial knee replacement, instruments required for supporting supplier implant products within this Lot category.
• 1.3: Orthopaedic Extremities Arthroplasty: Shoulder, elbow, ankle, finger, thumb and wrist joint reconstruction and fracture management through prosthetic implantation of an arthroplasty product, instruments required for supporting supplier implant products within this Lot category.
• 1.4: Complex Arthroplasty: Revision hip and knee joint replacement Upper & Lower Limb Orthopaedic Salvage systems – offering a full salvage portfolio for comprehensive reconstruction in revision or oncology.
• 1.5: Orthopaedic Internal & External Fixation: All fixation by way of plates, screws and nail implants used in emergency trauma and elective non-joint reconstruction / congenital correction implants utilised in sub-specialty orthopaedic surgery, external fixation devices and consumables equipment, single use instruments and instruments used to support products within this Lot category.
• 1.6: Spine: Orthopaedic spinal implants and consumables including spine specific cements and tissue substitutes, equipment consumables, single use instruments and instruments utilised in spine surgery and to support products within this Lot category.
• 1.7: Arthroscopy / Sports Medicine: All Implants utilised for soft tissue repair and mobilisation. All specific consumable items required for arthroscopic surgery including specialist instrumentation, consumables for fluid management, resection and ablation.
• 1.8: Bone Preparation: Bone cement, mixing systems, disposable pulse lavage and pulse lavage consumables as part of integrated power tool systems, associated products, equipment, instruments and supporting services.
• 1.9: Orthopaedic Power Tools Consumables: All consumables which are used with orthopaedic large bone, trauma, small bone, and high-speed power tools. This includes saw blades, burrs and drills*(other drills as part of trauma/spine implant systems in Lot categories 1.5 and 1.6 respectively)
• 1.10: Regenerative Technology: All biologic and synthetic, bone and soft tissue substitutes, associated instruments and supporting services. Early Intervention Devices (NON-PHARMACEUTICAL)
• 1.11: Orthopaedic Additional Devices: Consumables and products which support suppliers’ submission to Lot 2 should be included here. This includes single use or limited use, but routinely re-ordered products. Included here for example are: Hoods & togas, tourniquet, robotic and navigation consumables, ultrasound cement removal consumables.

This does not include Lot 1 specific consumables which should be allocated to the relevant Lot category e.g. arthroscopy consumables (Lot category 1.7), bone prep consumables (Lot category 1.8), power tool consumables (Lot category 1.9), consumables to support implantation of supplier brands (patient specific jigs, hip cup / trauma drills etc).

• 1.12: Custom/Customisable Implants: Custom made and customisable Implants, all supportive accessories, and services to support bespoke patient care for complex orthopaedic indications. Relevant products and their wraparound services which support all aspects of this framework in terms of bony/MSK anatomy and indication across Orthopaedics, Trauma and Spine.
• 1.13: Cranio-maxillofacial (CMF): All fixation by way of plates, screws and fixation devices / implants used in all emergency trauma and elective craniomaxillofacial surgery including reconstruction. This includes specialist external fixation devices, consumables, specialist consumables for associated equipment, single use instruments and instruments used to support products within this Lot category.