Large Fragment Screws & Plates Set – 4.5/6.5mm Orthopedic ORIF System

Large Fragment Screws Plates Set Combo, SKU PS-OP-4647, is a comprehensive 4.5 mm and 6.5 mm orthopedic fixation system supplied in the PS015 configuration with medical-grade stainless steel components. The 322-piece set combines 4.5 mm self-tapping cortex screws in 14–50 mm lengths, 6.5 mm cancellous bone screws with 16 mm and 32 mm thread configurations, 4.5 mm malleolar screws in 25–60 mm lengths, large washers, screw-holding forceps, and a broad selection of semi-tubular, narrow dynamic compression, broad dynamic compression, T, T-buttress, and L-buttress plates. The implant selection supports open reduction and internal fixation of adult long-bone and periarticular fractures where conventional large-fragment fixation is indicated. Typical orthopedic workflows include fixation of femoral, tibial, humeral, ankle, and other large-fragment fractures, with cancellous fixation used in metaphyseal bone and malleolar fixation used around the ankle. The configuration is suited to orthopedic trauma surgeons, fracture specialists, hospital operating rooms, orthopedic centers, surgical distributors, and medical procurement departments requiring a broad large-fragment implant inventory in one organized system.

Mechanical Architecture for Large-Fragment Fixation

The PS015 configuration combines plate geometries and screw families so the surgeon can select fixation according to cortical purchase, cancellous bone quality, fracture morphology, and required plate span. The 4.5 mm self-tapping cortex screws are designed for engagement with cortical bone, while their multiple lengths allow the surgeon to match bicortical or appropriate unicortical purchase to the selected plate and bone segment. The 6.5 mm cancellous screws provide larger-diameter fixation with either a 16 mm or 32 mm threaded portion, supporting different metaphyseal and epiphyseal fixation strategies. Dynamic compression plates use specially shaped holes that permit eccentric screw placement to generate axial compression across a fracture when the plate is applied according to standard AO principles. Broad and narrow profiles provide different plate widths and spans, while semi-tubular plates accommodate smaller contour requirements. T-plates and buttress configurations provide broader support at metaphyseal surfaces, and the L-buttress options provide directional support for right- or left-sided fracture patterns. The screw-holding forceps assists controlled handling and positioning of fixation components during preparation and application.

Orthopedic Trauma Workflow and Fracture Indications

This system is configured for conventional open reduction and internal fixation workflows in adult orthopedic trauma. During fracture exposure and reduction, the surgeon evaluates fragment geometry, bone quality, plate position, and required fixation length before selecting the appropriate plate profile. A narrow or broad 4.5 mm dynamic compression plate can be selected for diaphyseal fixation of the femur, tibia, or humerus when axial compression and conventional plate fixation are appropriate. Semi-tubular plates are suited to applications requiring a lower-profile plate, including selected distal tibial or fibular fixation patterns. The 4.5 mm malleolar screws provide dedicated length options for ankle fracture fixation, particularly when fixation requires controlled screw purchase around the malleoli. The 6.5 mm cancellous screws are selected for metaphyseal or cancellous bone, including fracture regions where larger threads are appropriate for bone purchase. T and T-buttress plates support fracture configurations requiring a transverse head or buttress effect, while right- and left-angled L-buttress plates provide directional support at selected metaphyseal fracture sites. Final implant selection remains based on fracture pattern, radiographic assessment, bone quality, reduction, and the surgeon’s established fixation technique.

Plate Profiles, Screw Dimensions, and Set Configuration

The cortex screw inventory contains 4.5 mm self-tapping screws from 14 through 50 mm, with increased quantities across commonly used intermediate lengths. The cancellous inventory contains 6.5 mm screws with 16 mm thread lengths from 25 through 110 mm and 32 mm thread lengths from 40 through 90 mm, providing distinct options for metaphyseal fixation and deeper cancellous purchase. The 4.5 mm malleolar screw series extends from 25 through 60 mm. Four semi-tubular plates are supplied with 4, 5, 6, and 7 holes. Twelve narrow dynamic compression plates cover 5–10 holes, while twelve broad dynamic compression plates range from 6 through 16 holes. Five T-plates and five T-buttress plates provide 4–8 shaft holes, and the set includes one right/left-angled L-buttress configuration and one left/right-angled counterpart, each with four holes. Twelve large washers and one screw-holding forceps complete the fixation accessories. The 015.000 empty container provides organized storage for the complete configuration, allowing the operating-room team to maintain screw lengths and plate geometries in a structured implant inventory.

Large Fragment Screws Plates Set Combo

Details of Large Fragment Screws & Plates Set - Combo is Given Below.

Stainless Steel Construction, Processing, and Procurement

The fixation components are supplied in medical-grade stainless steel, providing the material characteristics required for conventional orthopedic implant construction and controlled surgical handling. The metallic surfaces have a smooth machined finish that supports visual inspection, cleaning, and organized tray presentation. Implant components are supplied as sterile-use surgical inventory according to the applicable product packaging and institutional processing requirements, while reusable accessory instruments such as the screw-holding forceps require cleaning, inspection, and validated sterilization between procedures. For reusable metal accessories, steam sterilization is performed according to the validated cycle and instructions applicable to the device, with attention to complete cleaning of joints and contact surfaces before sterilization. Plates and screws intended for implantation are not treated as reusable instruments after patient use. The product page identifies CE, FDA, and ISO certification documentation, supporting regulated procurement review for healthcare organizations. ISO 13485 relates to the manufacturer’s medical-device quality management system, while CE marking supports applicable European conformity requirements and FDA-related documentation supports United States procurement evaluation. Hospitals and distributors should maintain device traceability, packaging integrity, lot information, and applicable regulatory documentation within their procurement and inventory systems.

How does this set differ from a locking compression plate system?
Large Fragment Screws Plates Set Combo is based on conventional 4.5 mm plate fixation rather than a fixed-angle locking interface. Its dynamic compression plate holes allow eccentric screw placement to generate axial compression across a fracture. A locking compression plate uses threaded plate holes that engage compatible locking screw heads to create fixed-angle constructs. Conventional compression plating can provide direct fragment compression when appropriate reduction and plate application techniques are used. The present configuration therefore suits surgeons using established non-locking large-fragment fixation techniques. The 4.5 mm cortex screws provide standard cortical purchase through the plate. The choice between conventional and locking constructs depends on fracture morphology, bone quality, soft-tissue conditions, and the surgeon’s fixation strategy.

How should the 4.5 mm and 6.5 mm screw sizes be selected?
The 4.5 mm cortex screws are intended for cortical bone fixation and are available from 14 to 50 mm in this configuration. They are commonly selected for diaphyseal fixation of large bones such as the femur, tibia, and humerus when conventional plating is indicated. The 6.5 mm cancellous screws provide larger-diameter threads for cancellous and metaphyseal bone. The 16 mm thread option covers a broad length range from 25 to 110 mm, while the 32 mm thread option covers 40 to 90 mm. Malleolar screws are 4.5 mm in diameter and range from 25 to 60 mm for ankle fixation workflows. The correct length is determined from intraoperative measurement, bone dimensions, plate position, and the intended depth of purchase. Large Fragment Screws Plates Set Combo provides multiple lengths so the implant can be selected for the individual fracture and anatomical site.

What do CE, ISO 13485, and FDA procurement references mean for hospitals?
The product page identifies CE, FDA, and ISO certification documentation for the Large Fragment Screws Plates Set Combo. CE marking indicates conformity with applicable European regulatory requirements for the marketed device. ISO 13485 refers to the medical-device quality management system used for controlled manufacturing and quality processes. FDA procurement documentation supports evaluation for United States healthcare purchasing and regulatory requirements. Hospitals should review the applicable device documentation, labeling, intended use, and regulatory status required by their jurisdiction before procurement. Distributor purchasing teams can incorporate the available certification documentation into supplier qualification and product records. Regulatory acceptance remains subject to the healthcare organization’s procurement policy and the requirements of the destination market.

What is the function of the screw-holding forceps during surgery?
The included screw-holding forceps is used to grasp and control individual fixation screws during handling and placement. Its purpose is mechanical control of the small implant component rather than fracture reduction itself. The instrument can assist the scrub team or surgeon when transferring selected screw lengths from the tray to the operative field. Controlled handling reduces the need to manipulate the threaded component directly with fingers. It is particularly useful when organizing multiple 4.5 mm and 6.5 mm screw lengths during an ORIF procedure. After use, the reusable forceps requires appropriate cleaning, inspection, and validated sterilization. The plates and screws themselves are implant components and are not reused after implantation.

How should hospitals process and manage this set for procurement and sterilization?
Operating-room teams should maintain the screws and plates in their organized container with size and configuration identification preserved. Implant packaging should be inspected for integrity, labeling, traceability information, and applicable expiration or storage requirements before use. Reusable accessory instruments should undergo validated cleaning and steam sterilization according to the applicable device instructions and facility protocol. The implant components should be handled as single-patient-use fixation components and should not be returned to inventory after clinical implantation. Procurement departments can maintain the SKU PS-OP-4647 against purchase records, lot information, regulatory documentation, and inventory controls. The 322-piece configuration provides a broad range of implant dimensions for orthopedic trauma inventory management. Distributors and hospitals can also use the documented plate and screw configuration when planning replenishment or institutional set requirements.