| 1 |
Joint replacement implant supplier |
Hip and knee replacement components, including femoral, acetabular, and tibial components |
Titanium alloys, cobalt-chromium alloys, stainless steel, and ultra-high-molecular-weight polyethylene (UHMWPE) |
Reamers, broaches, trials, alignment guides, and impactors |
ISO 7206 series for hip-joint prostheses; ISO 14879-1 for endurance testing of knee tibial trays; ISO 5832 series for specified implant metals |
| 2 |
Trauma fixation implant supplier |
Bone plates, screws, intramedullary nails, and related fracture-fixation components |
Implant-grade stainless steel and titanium alloys |
Drill guides, depth gauges, screwdrivers, plate benders, and targeting instruments |
ISO 5832-1 covers implant-grade stainless steel; ISO 5832-3 covers wrought titanium-6-aluminium-4-vanadium alloy |
| 3 |
Spinal implant supplier |
Pedicle screw-rod systems, interbody devices, and spinal fixation components |
Titanium alloys, stainless steel, and polymer materials such as PEEK in applicable device designs |
Screwdrivers, rod holders, trial spacers, distractors, and insertion instruments |
ISO 13485 addresses medical-device quality management systems; device-specific requirements and testing depend on the product |
| 4 |
Sports medicine implant supplier |
Anchors and fixation devices used in ligament, tendon, and soft-tissue procedures |
Titanium alloys, stainless steel, and selected absorbable or polymer materials |
Insertion drivers, guide wires, suture passers, and tensioning instruments |
Material and performance requirements vary with device design and intended use; risk management is addressed by ISO 14971 |
| 5 |
External fixation system supplier |
External fixation frames, clamps, connecting rods, and fixation pins |
Stainless steel, titanium alloys, and aluminum alloys for applicable external components |
Pin drivers, clamps, wrenches, cutting tools, and frame assembly instruments |
Product-specific mechanical testing and applicable medical-device regulatory requirements depend on intended use and configuration |
| 6 |
Maxillofacial fixation supplier |
Small plates, screws, and fixation systems for facial and craniofacial applications |
Titanium and implant-grade stainless steel; material selection depends on the intended application |
Small-joint drivers, plate contouring tools, drill guides, and depth gauges |
ISO 5832-1 and ISO 5832-3 specify requirements for particular implant metal materials |
| 7 |
Orthopedic surgical instrument supplier |
Reusable instruments for bone preparation, implant insertion, and alignment |
Instrument-grade stainless steel and other materials selected for the instrument’s function |
Retractors, forceps, osteotomes, rasps, mallets, and measuring instruments |
ISO 7153-1 specifies metals used for surgical instruments; cleaning, sterilization, and reuse instructions are device-specific |
| 8 |
Powered orthopedic tool supplier |
Powered systems and attachments used for bone cutting, drilling, or reaming |
Materials vary by component; patient-contacting parts require evaluation for their intended use |
Drills, saws, reamers, handpieces, and compatible accessories |
Applicable electrical safety and performance requirements depend on the equipment type and intended clinical environment |
| 9 |
Bone graft and orthopedic biomaterial supplier |
Selected bone void fillers and materials used in orthopedic procedures |
Material composition varies and may include synthetic calcium-phosphate-based or other specified biomaterials |
Mixing, delivery, or placement instruments where supplied as part of the product system |
Composition, biological evaluation, and product-specific regulatory requirements depend on the material and intended use |
| 10 |
Contract manufacturing and OEM supplier |
Manufacturing services for orthopedic implants, components, and surgical instruments to customer specifications |
Materials are selected according to the customer’s design, technical specifications, and applicable requirements |
Manufacturing, inspection, and assembly tooling; clinical instruments may be included under a customer-controlled design |
ISO 13485 is a medical-device quality management system standard; applicable Chinese registration and compliance duties depend on the product and regulatory role |