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.

Specific Orthopaedic Equipment used in orthopaedic, trauma and spine theatres which includes but is not limited to: Robotics, Navigation, Imaging, Fluid management, Arthroscopic consoles & stack systems, High speed power tools, Large and small bone power tools & Reusable Pulse Lavage, Helmets, Tourniquets machines, Bone harvesting / milling, Ultrasound cement removal, Cement mixing capital equipment, Ultrasound bone healing, Neuromonitoring (spine surgery), Autologous Bone Marrow, Aspirate, Autologous Blood Transfusion, Autologous Platelet Rich Plasma, Other Autologous Systems This excludes generic equipment such as those used in general surgery.

Supportive services, solutions, products, and programs which aid in the treatment of patients undergoing Orthopaedic pathway procedures e.g. patient wearable devices, patient/clinician applications, procedure / patient planning software, orthopaedic managed equipment servicing, technical support, operational efficiency programs and value healthcare solutions.

Procurement Act 2023

Open procedure

NHS Supply Chain seeks to establish a Total Orthopaedic Solutions 4 framework intended to cover Implants and Consumables (including Orthopaedic Primary and Hemiarthroplasty Hips, Orthopaedic Primary and Partial Knees, Orthopaedic Extremities Arthroplasty, Complex Arthroplasty, Orthopaedic Internal & External Fixation, Spine, Arthroscopy / Sports Medicine, Bone Preparation, Orthopaedic Power Tools Consumables, Regenerative Technology, Orthopaedic Additional Devices and Custom/Customisable Implants), Orthopaedic Equipment and Services and Solutions. It is anticipated that in the first 12 months of the Framework Agreement the value of purchases will be circa £711,000,000.00 (exc VAT) however this is approximate only and may vary depending on requirements of bodies purchasing under the Framework. The Framework Agreement between NHS Supply Chain and successful Tenderers will reserve the right to purchase the same or similar supplies from Tenderers not appointed to the Framework at its sole discretion. For Goods/Services ordered via the Transacted Routes of Supply as set out in the Framework Agreement Award Pack, only the Authority will be entitled to place Orders which it will then make available for purchase by: 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body; and/or 4) any private sector entity active in the UK healthcare sector.

The Framework Agreement will be between NHS Supply Chain and the Tenderer, however only the Authority will be entitled to place Orders which it will then make available for purchase by: 1) any NHS Trust; 2) any other NHS entity; 3) any government department, agency or other statutory body; and/or 4) any private sector entity active in the UK healthcare sector. Electronic ordering will be used and electronic invoicing will be accepted and electronic payment will be used. For the avoidance of doubt, and notwithstanding the estimate indicated within the scope, NHS Supply Chain does not guarantee any level of purchase through the framework and advises Tenderers that the framework shall be established on a non-exclusive basis. Tenders and all supporting documentation for the contract must be priced in sterling and written in English. Any agreement entered into will be considered a contract made in England according to English law and will be subject to the exclusive jurisdiction of the English Courts. NHS Supply Chain is not liable for any costs (including any third party costs fees or expenses incurred by those expressing an interest, participating or tendering for this contract opportunity. NHS Supply Chain reserves the right to terminate the procurement process (or part of it), to change the basis of and the procedures for the procurement process at any time, or to procure the subject matter of the contract by alternative means if it appears that it can be more advantageously procured by alternative means. The most economically advantageous or any tender will not automatically be accepted. All communications must be made through NHS Supply Chain's eTendering portal at https://nhssupplychain.app.jaggaer.com// using the Message Centre facility linked to this particular contract notice. INSTRUCTIONS FOR REGISTRATION AND PORTAL ACCESS Submission of expression of interest and procurement specific information: This procurement exercise will be conducted on the NHS Supply Chain eTendering portal at: https://nhssupplychain.app.jaggaer.com// Suppliers wishing to be considered for this contract must register their expression of interest and provide additional procurement-specific information (if required) through the NHS Supply Chain eTendering portal as follows: Registration. 1. Use URL https://nhssupplychain.app.jaggaer.com// to access the NHS Supply Chain Procurement portal. 2. If not yet registered: — Click on the ‘Not Registered Yet’ link to access the registration page. — Complete the registration pages as guided by the mini guide found on the landing page. Portal access. If registration has been completed: — Login with URL https://nhssupplychain.app.jaggaer.com// . — Click on ITTs Open to All Suppliers. — Select from the following ITTs: ITT_2391 - Procurement Specific Questionnaire All Lots ITT_2380 - Lot 1 - Implants and Consumables ITT_2381 - Lot 2 - Orthopaedic Equipment ITT_2382 - Lot 3 - Services & Solutions — Click on 'Express Interest' — Read' Information' dialogue box then 'Confirm' IMPORTANT: Please note you MUST respond to ITT_2391, AND one/or all Lot specific ITT's. Suppliers are strongly advised to read all of the tender documentation provided thoroughly to know how to submit a fully compliant Tender before the submission deadline. Suppliers are encouraged to download the supplier handbook located within the eProcurement portal by following the 'Supplier Helpcentre' link within the Useful Links section of the Dashboard. For any technical help with the portal please contact: Tel: 0800 069 8630 or via Request Assistance/Live Chat Please refer to Section III.1.1 for additional information All tender submissions must be submitted online via the Jaggaer Qualification, Technical and Commercial Envelopes in compliance with the published tender documentation. Tenders submitted by any other means than the eProcurement Portal response envelopes will not be accepted.