| Titanium Material Grade | Confirm the implant-grade titanium or titanium alloy used for the anchor and verify that the material is consistent across batches. | Commercially pure titanium may be documented under ASTM F67 or ISO 5832-2. Titanium alloys should be supported by the applicable material specification, such as ASTM F136 where relevant. | Material certificate, chemical composition report, heat or lot number, and independent laboratory verification when required. | 15% |
| Biocompatibility | Assess biological safety of the finished anchor, coating, suture interface, and any processing residues. | Evaluation should follow the applicable parts of ISO 10993 based on the device’s nature, duration, and type of tissue contact. | Biological evaluation plan, test reports from qualified laboratories, toxicological assessment, and raw-material declarations. | 15% |
| Design and Intended Use | Check anchor size, thread or fixation design, insertion method, eyelet geometry, and compatibility with the intended surgical procedure. | The design should be supported by documented engineering specifications, risk analysis, and performance testing for the stated anatomical application. | Approved drawings, design history records, instructions for use, surgical technique documentation, and risk-management file. | 12% |
| Mechanical Performance | Evaluate pull-out strength, suture retention, eyelet strength, torsional resistance, insertion torque, and fatigue performance where applicable. | Test methods should represent the intended bone quality, insertion technique, anchor configuration, and worst-case product size. Acceptance limits must be defined before testing. | Validated bench-test protocols, raw data, statistical analysis, failure-mode records, and reports for the smallest or worst-case configuration. | 15% |
| Surface Finish and Cleanliness | Inspect surface defects, burrs, sharp edges, loose particles, machining residues, and visible contamination. | The finished device should meet approved visual, dimensional, particulate, and cleanliness specifications. Surface roughness limits should be defined in the product specification where relevant. | Inspection standards, microscopy records, cleanliness test reports, passivation or cleaning records, and retained samples. | 10% |
| Dimensional Accuracy | Verify anchor diameter, length, thread profile, eyelet dimensions, insertion-driver interface, and suture passage dimensions. | Critical dimensions should have controlled tolerances, calibrated measurement methods, and documented inspection results for each production lot. | Inspection reports, calibrated equipment records, first-article inspection, and lot-release dimensional data. | 8% |
| Sterilization and Packaging | Confirm the sterilization method, sterilization validation, packaging integrity, and claimed shelf life. | For sterile products, the process should be validated for the selected method, such as ethylene oxide or radiation, and packaging should maintain sterility through the stated shelf life. | Sterilization validation, residual testing where applicable, package integrity testing, accelerated-aging data, and transport simulation results. | 10% |
| Quality Management System | Assess control of design, purchasing, production, nonconformities, corrective actions, traceability, and document changes. | A medical-device quality system is commonly demonstrated through ISO 13485 certification, but the certificate scope and validity must match the actual product and manufacturing site. | Current certificate, audit report or audit summary, certificate scope, corrective-action records, and change-control procedures. | 8% |
| Regulatory Documentation | Confirm whether the product is legally marketed in the target country and whether the technical file supports the intended claims. | Regulatory requirements differ by market. Do not treat a quality certificate, test report, or export record as a substitute for market authorization. | Declaration or approval documents, product registration information, labeling review, clinical or performance justification, and post-market procedures. | 5% |
| Supplier Traceability and Capacity | Evaluate traceability from raw material to finished device and verify the supplier’s ability to maintain consistent production volumes. | Each finished lot should be linked to raw-material lots, processing records, inspection results, sterilization records, and release authorization. | Sample batch record, traceability procedure, production-capacity data, equipment-maintenance records, and business-continuity plan. | 2% |