The 4.5 mm Monoaxial Pedicle Screw Spine System 21 Pcs is a specialized orthopedic spinal fixation system designed for professional use in appropriately selected spinal stabilization procedures. The system combines 4.5 mm pedicle screws, double-thread design, monoaxial screw heads, rods, and clamps to create a comprehensive posterior spinal fixation configuration. With 21 total components, the system provides essential implant elements for constructing a compatible pedicle-based stabilization assembly.

Pedicle screw fixation is widely used in spinal surgery to provide segmental stabilization of selected vertebral levels. Pedicle screws are inserted through the vertebral pedicles into the vertebral body or appropriate posterior vertebral structures according to the specific surgical technique. When connected with longitudinal rods and secured using compatible clamps or locking components, the system can create a rigid fixation construct intended to support spinal alignment and stabilization.

The 4.5 mm screw diameter provides a defined fixation profile for applications where this size is appropriate. Screw diameter and length must be selected according to the vertebral level, patient anatomy, bone quality, imaging findings, and the requirements of the specific spinal procedure. The product title specifies the screw diameter but does not identify individual screw lengths, so the final implant selection should be based on the actual available configuration and manufacturer specifications.

The double-thread design is intended to provide threaded bone engagement and efficient advancement during insertion when used with compatible instrumentation and according to the manufacturer’s surgical technique. Thread configuration can influence screw insertion characteristics and fixation behavior, making appropriate surgical preparation and controlled placement important during implantation.

The monoaxial screw design provides a fixed-angle relationship between the screw shaft and the screw head. Unlike polyaxial pedicle screws, monoaxial screws do not provide the same degree of head angulation relative to the screw shaft. This characteristic can be advantageous in specific spinal fixation constructs where controlled alignment and a fixed screw-head orientation are desired. The suitability of monoaxial fixation depends on the patient’s anatomy, surgical objective, vertebral level, and surgeon preference.

The included rod and clamp components are designed to connect and secure the pedicle screws into a unified spinal fixation construct. Longitudinal rods can span multiple instrumented vertebral levels, while compatible clamps or locking components secure the rod to the pedicle screw assembly. Correct compatibility between screws, rods, clamps, and insertion instruments is essential and must be verified according to the manufacturer’s specifications.

This 21-piece spinal fixation system can provide a practical implant configuration for professional spinal surgery inventory. The system may be appropriate for hospitals, spine surgery centers, orthopedic departments, neurosurgical facilities, and authorized medical-device distributors that require pedicle screw fixation components for selected spinal stabilization procedures.

Pedicle screw systems may be used in various spinal procedures depending on the clinical indication and implant design. Applications can include stabilization of selected spinal instability conditions, deformity correction, trauma-related instability, and other indications determined by a qualified spine surgeon. The specific indication for this 4.5 mm monoaxial system should always be established according to the manufacturer’s approved labeling and the patient’s clinical requirements.

Proper implant handling is essential for maintaining device integrity. The 4.5 mm pedicle screws, rods, and clamps should be stored, inspected, handled, and implanted according to the manufacturer’s instructions for use and applicable medical-device regulations. Implantable components designated for single use should not be reused. Reusable surgical instruments used for pedicle screw placement and rod assembly should undergo validated cleaning, inspection, packaging, and sterilization procedures according to manufacturer instructions and healthcare-facility protocols.

The Pedicle 4.5 mm Double-Thread Monoaxial Screw Spine System with Rod & Clamp – 21 pcs provides a structured spinal fixation solution combining monoaxial pedicle screws with compatible rod and clamp components. Its 4.5 mm screw profile, double-thread configuration, and fixed-head monoaxial design make it suitable for professional spinal stabilization applications where this specific implant configuration is clinically indicated.

Key Features

• 4.5 mm pedicle screw spinal fixation system
• Double-thread screw design for appropriate pedicle fixation applications
• Monoaxial screw head provides a fixed screw-head orientation
• Complete 21-piece spinal fixation system
• Includes compatible rods and clamps
• Designed for posterior spinal stabilization procedures
• Provides segmental vertebral fixation when appropriately indicated
• Rod-and-clamp configuration creates a connected spinal fixation construct
• Suitable for selected orthopedic and neurosurgical spine procedures
• Multiple components support professional spinal implant configuration
• Screw dimensions should be selected according to patient anatomy and manufacturer specifications
• Intended for use by qualified spine surgeons according to approved surgical technique

Product Specifications

FAQs

1. What is a 4.5 mm Pedicle Screw Spine System used for?

A 4.5 mm Pedicle Screw Spine System is designed for selected spinal stabilization procedures in which pedicle-based fixation is clinically indicated. The screws are connected to rods using compatible clamps or locking components to create a spinal fixation construct.

2. What does monoaxial mean in a pedicle screw?

A monoaxial pedicle screw has a fixed relationship between the screw shaft and screw head. Unlike a polyaxial screw, the head does not freely articulate through a range of angles relative to the shaft.

3. What does double-thread mean on a pedicle screw?

A double-thread design refers to the thread configuration of the screw and can facilitate efficient advancement during insertion when used with compatible surgical instrumentation. Exact insertion characteristics depend on the specific screw geometry.

4. What components are included in this 21-piece spinal system?

The system is specified as a 21-piece configuration containing 4.5 mm double-thread monoaxial pedicle screws with rods and clamps. The exact distribution of individual components should be confirmed against the manufacturer’s product configuration.

5. What is the purpose of the rod in a pedicle screw system?

The spinal rod connects multiple pedicle screw assemblies and helps create a continuous fixation construct across the instrumented spinal levels. Rod dimensions and compatibility must correspond to the selected screw and clamp system.

6. What is the purpose of the clamp in a spinal fixation system?

The compatible clamp or locking component secures the rod to the pedicle screw assembly. Proper locking and tightening should be performed using the manufacturer’s specified instruments and surgical technique.

7. Can 4.5 mm pedicle screws be used at every spinal level?

No. Pedicle screw diameter and length must be selected according to the patient’s anatomy, vertebral level, pedicle dimensions, bone quality, imaging findings, and the specific implant system. A qualified spine surgeon should determine the appropriate screw size.

8. What surgical procedures can use pedicle screw fixation?

Pedicle screw systems may be used in selected spinal stabilization procedures, including certain trauma, deformity, instability, and reconstructive applications. The approved indications depend on the specific implant system and manufacturer labeling.

9. How should pedicle screws, rods, and clamps be sterilized?

Implantable components should be handled according to the manufacturer’s validated instructions for use. Reusable surgical instruments should be cleaned, inspected, packaged, and sterilized using validated healthcare-facility procedures consistent with manufacturer requirements.