Spine Pedicle Screw Instrument Set – 31-Piece Posterior Fixation Instrumentation with Polyaxial and Monoaxial Screwdrivers (PS-OS-00300-09)

The Spine Pedicle Screw Instrument Set (PS-OS-00300-09, REF 2200-01 series) is a complete 31-piece stainless steel ancillary instrumentation kit supplied in an aluminium case, designed for the implantation of polyaxial and monoaxial pedicle screw and rod fixation systems in posterior spinal fusion procedures for degenerative, traumatic, and deformity indications. The set provides every instrument required across the full procedure sequence: straight and bent pedicle probes and an awl for pedicle entry point preparation and cannulation, straight and bent feelers for confirming pedicle wall integrity along the screw channel, a tap series (φ4.0, φ5.5, φ6.0, and φ7.0mm) for thread preparation matched to screw diameter, dedicated screwdrivers for polyaxial and monoaxial pedicle screws, a trial rod for intraoperative length and contour assessment, a rod bender for in-situ rod contouring, rod pushing and rod holding forceps and a rod pusher for rod delivery and seating into the screw heads, parallel spreader and parallel compressor instruments for segmental distraction and compression during rod reduction, a rod twist instrument for rod derotation maneuvers, hex screw nut holders and crosslink nut holders with their corresponding hex screwdrivers for final screw locking, a screw cutter with counter torque for trimming excess length from long-arm (extended tab) polyaxial screws after rod placement, an insert device for fixation pin placement, and T-handle and straight-handle quick couplings for driveshaft instrumentation. Manufactured from surgical-grade stainless steel for repeated steam autoclave sterilization across the operative service life of the set. Used by spine surgeons and neurosurgeons performing posterior pedicle screw fixation procedures in hospital spine surgery suites and neurosurgical operating rooms. Supplied complete in the aluminium case.

Pedicle Screw Fixation Workflow and the Role of This 31-Piece Set

Posterior pedicle screw fixation is the technique of placing screws through the pedicles of the vertebral bodies into the vertebral body itself, then connecting these screws across one or more vertebral levels with longitudinal rods to achieve segmental stabilization, deformity correction, or fracture reduction. This instrument set is configured to support each stage of this procedure. Pedicle entry point preparation begins with the AWL, used to penetrate the dorsal cortex at the planned pedicle entry point — typically at the junction of the transverse process and the superior articular facet — establishing the starting point for pedicle cannulation. The straight and bent pedicle probes are then used to cannulate the pedicle, following the cancellous bone corridor through the pedicle isthmus into the vertebral body while maintaining the trajectory that avoids medial, lateral, superior, and inferior pedicle wall breach — the bent probe provides an alternative access angle for levels where the straight probe's trajectory is obstructed by adjacent anatomy. After cannulation, the straight and bent feelers are passed along the prepared channel to palpate the pedicle walls and confirm that all four walls (medial, lateral, superior, inferior) remain intact — feeler confirmation is a critical safety step because a breached medial pedicle wall risks screw malposition into the spinal canal with potential neurological injury. The appropriate tap (φ4.0, φ5.5, φ6.0, or φ7.0mm, selected to match the planned screw diameter) is then used to create the screw thread path in the prepared channel, after which the polyaxial or monoaxial screwdriver — selected according to the screw head design — is used to insert the pedicle screw to the planned depth.

Polyaxial vs Monoaxial Screwdrivers: Screw Head Design and Insertion Technique

This set includes dedicated screwdrivers for both polyaxial and monoaxial pedicle screw designs, reflecting the two fundamental screw head architectures used in modern pedicle screw systems and the different insertion considerations each requires. Polyaxial screws have a screw head that can pivot relative to the screw shaft across a range of angles before being locked in its final orientation by the screw nut — this design accommodates variation in screw trajectory relative to the rod path, which is particularly valuable in multi-level constructs and deformity correction where the angular relationship between adjacent screw heads and the rod varies significantly along the construct. The polyaxial screwdriver engages the screw head while allowing the head to remain mobile relative to the shaft during insertion, permitting the surgeon to drive the screw to the planned depth along the pedicle trajectory independent of the final head orientation, which is adjusted afterward during rod seating. Monoaxial screws have a screw head in a fixed orientation relative to the shaft — the head angle is set during manufacture and does not change. Monoaxial screws provide greater rigidity at the screw-rod junction because there is no polyaxial mechanism to introduce micromotion, which can be advantageous in constructs where maximum segmental rigidity is the priority, such as certain deformity correction constructs where controlled force transmission through the screw-rod junction is part of the correction maneuver. The monoaxial screwdriver engages the fixed screw head directly, and because the head orientation is fixed, accurate trajectory planning before screw insertion is more critical with monoaxial screws than with polyaxial screws, as there is no subsequent head reorientation to compensate for trajectory deviation.

Rod Contouring, Reduction, and Seating Instrumentation

After pedicle screws are placed at all planned levels, the rod must be contoured to match the patient's sagittal and coronal spinal alignment, then reduced into the screw heads and secured — the sequence supported by this set's rod-handling instruments. The trial rod is used first, placed across the screw heads without final contouring to assess the rod length required and to visualize the gap between the trial rod and each screw head, informing the contouring that the definitive rod will require. The rod bender applies controlled bending force to the definitive rod at specific points to create the sagittal and coronal contour matching the patient's anatomy and the planned correction — in-situ bending using the in-situ bending iron can also be performed after the rod is partially seated, allowing final contour adjustments with the rod already engaged in some screw heads. Rod delivery into the screw heads is performed using the rod pushing forceps and rod pusher, which apply controlled force to seat the rod into each screw head's saddle. Where the rod sits proud of a screw head — a gap that must be closed for the screw nut to engage — the parallel spreader and parallel compressor provide the segmental distraction or compression force needed to bring the screw head and rod into alignment: the parallel compressor draws two adjacent screw heads together (useful for closing a gap or achieving segmental compression for fracture reduction), while the parallel spreader pushes two adjacent screw heads apart (useful for restoring disc height or foraminal height during deformity correction). The rod holding forceps stabilizes the rod during these reduction maneuvers, and the rod twist instrument applies a derotation force to the rod — used in deformity correction techniques where rod derotation translates coronal curvature into sagittal correction.

Final Locking: Screw Nuts, Crosslink Nuts, and Long-Arm Screw Trimming

Once the rod is fully seated in all screw heads at the planned alignment, the screw nuts are tightened to lock the rod into each polyaxial screw head, fixing the final angular relationship between each screw and the rod. The hex screwdriver for screw nut and the screw nut holder hex work together for this step — the holder stabilizes the screw head's extended tab (in long-arm screw designs) while the screwdriver applies the final tightening torque to the screw nut, with the counter torque instrument used to prevent the screw itself from rotating within the bone during nut tightening, which would loosen the screw's bony purchase. Where a crosslink — a transverse connector between the rods on either side of the spine — is used to add torsional rigidity to the construct, the screwdriver hex 3.5mm for crosslink nut and the crosslink nut holder hex perform the analogous tightening function for the crosslink connections. After all screw nuts are tightened, many polyaxial screw designs use a long-arm or extended-tab configuration during insertion and reduction — the extended tab provides additional leverage for screw insertion and rod reduction maneuvers — and this extended tab must be removed once the construct is finalized. The screw cutter for long arm screw, used with its counter torque, trims the extended tab flush with the screw head, leaving the low-profile final screw head configuration appropriate for wound closure. The T-handle quick coupling and straight handle quick coupling provide the driveshaft connections used throughout the procedure for the taps, probes, and other instruments requiring rotational driving force, with the two coupling types offering different ergonomic options depending on the access angle and surgeon preference at each step.

CE Mark, ISO 13485, and FDA Certification for Spinal Instrument Set Procurement

The Spine Pedicle Screw Instrument Set PS-OS-00300-09 is manufactured under a quality management system certified to ISO 13485, governing surgical-grade stainless steel material sourcing, precision machining of all probing, tapping, screwdriving, rod-handling, and locking instruments, dimensional inspection across all 31 components, aluminium case fabrication, and final set assembly and packaging. CE Mark certification confirms conformity with European Medical Device Regulation requirements for reusable spinal surgical instrument sets distributed within EU and associated regulatory territories. FDA compliance documentation is maintained for United States distribution, satisfying regulatory requirements applicable to reusable spinal instrumentation procured by US hospitals, spine surgery centers, and orthopedic and neurosurgical instrument distributors. These certifications satisfy procurement and tender documentation requirements of institutional buyers in the USA, India, Pakistan, Vietnam, and across international spinal surgical supply frameworks. Certificates of conformity and quality management system documentation are available on request. OEM manufacturing and custom set configurations are available within the same certified manufacturing framework.

Product Specifications

Frequently Asked Questions

What procedure is this 31-piece instrument set designed for, and what does it allow the surgical team to do?
This set provides the complete ancillary instrumentation for posterior pedicle screw and rod fixation — the technique of placing screws through the vertebral pedicles and connecting them across levels with contoured rods for spinal stabilization, deformity correction, or fracture fixation. The set does not include the pedicle screws or rods themselves, which are implants supplied separately and selected according to the specific implant system in use; this set provides the instruments used to place and secure those implants. The procedure sequence supported includes pedicle entry preparation (AWL, straight and bent pedicle probes), pedicle wall confirmation (straight and bent feelers), thread preparation (φ4.0–φ7.0mm tap series), screw insertion (polyaxial or monoaxial screwdrivers depending on the screw system), rod sizing and contouring (trial rod, rod bender, in-situ bending iron), rod reduction (rod pusher, rod pushing and holding forceps, parallel spreader and compressor, rod twist), and final locking (screw nut and crosslink nut holders and screwdrivers, counter torque, and screw cutter for trimming long-arm screws). The aluminium case houses all 31 components for storage, transport, and sterilization between procedures.

What is the difference between polyaxial and monoaxial pedicle screws, and why does this set include separate screwdrivers for each?
Polyaxial pedicle screws have a screw head that can pivot relative to the screw shaft across a range of angles before being locked into its final position by tightening the screw nut — this mobility allows the screw head to align with the rod regardless of variation in the screw's insertion trajectory at each level, which is particularly useful in multi-level constructs where adjacent screw trajectories naturally vary. Monoaxial pedicle screws have a screw head fixed in a single orientation relative to the shaft, set during manufacture — there is no polyaxial pivot mechanism, which provides greater rigidity at the screw-rod junction with no micromotion, often preferred in specific deformity correction techniques where controlled force transmission through a rigid screw-rod junction is part of the correction maneuver. Because the screw head geometry and the way each screwdriver engages the head differ between these two screw designs, dedicated screwdrivers are required for each — using a polyaxial screwdriver on a monoaxial screw head, or vice versa, would not engage the screw head correctly for safe and effective insertion. Many spinal constructs use polyaxial screws at most levels with monoaxial screws at specific levels chosen for their rigidity characteristics, making both screwdrivers necessary in a complete instrument set.

What is the function of the parallel spreader and parallel compressor, and when is each used?
The parallel spreader and parallel compressor are reduction instruments that engage two adjacent pedicle screw heads (or screw extension tabs in long-arm screw systems) and apply a controlled force to change the distance between them — the spreader pushes the screw heads apart, and the compressor draws them together. These instruments are used during rod reduction and segmental alignment maneuvers. The parallel compressor is used when adjacent vertebral segments need to be brought closer together — for example, to achieve segmental compression across a fracture site to promote bony apposition and healing, or to close a gap between a screw head and the rod where the rod sits slightly proud and needs to be drawn down to the screw head saddle for the screw nut to engage. The parallel spreader is used when adjacent segments need to be distracted apart — for example, to restore disc space height or foraminal height that has been lost due to degenerative collapse, as part of indirect decompression of neural elements via foraminal height restoration. Both instruments apply this force directly between two screw heads, providing controlled, localized correction at the specific segment being addressed, distinct from global rod contouring which affects the overall sagittal and coronal alignment of the entire construct.

What is the purpose of the screw cutter for long-arm screws, and why is counter torque needed during this step?
Many polyaxial pedicle screw systems use a long-arm or extended-tab screw head design during the insertion and reduction phases of the procedure — the extended tabs provide additional leverage for the surgeon when inserting the screw, attaching reduction instruments, and performing rod reduction maneuvers that would be difficult to grip on a low-profile screw head alone. Once the rod is seated and the screw nut is tightened to lock the screw-rod relationship, these extended tabs serve no further function and must be removed to leave a low-profile final construct suitable for soft tissue closure without prominence. The screw cutter for long arm screw performs this trimming, cutting through the extended tab material at the designated breaking point built into the screw design. During this cutting step, the counter torque instrument is engaged on the screw head to prevent the screw itself from rotating within the vertebral body as the cutting force is applied — without counter torque, the torque from the cutting action could loosen the screw's bony purchase or alter its locked relationship with the rod, both of which would compromise construct stability at that level.

What certifications does this set carry, and are bulk or OEM orders available?
The Spine Pedicle Screw Instrument Set PS-OS-00300-09 is manufactured under an ISO 13485-certified quality management system covering surgical-grade stainless steel procurement, precision machining of all probing, tapping, screwdriving, rod-handling, reduction, and locking instruments, dimensional inspection across all 31 components, aluminium case fabrication, and final assembly. CE Mark certification confirms conformity with European Medical Device Regulation requirements for reusable spinal surgical instrument sets. FDA compliance documentation supports United States distribution. Certificates of conformity and quality management documentation are available on request for hospital procurement and tender processes. Bulk orders are accepted with a minimum of 1 set, with volume pricing available for hospitals, spine surgery centers, orthopedic and neurosurgical instrument distributors, and group purchasing organizations. OEM manufacturing for custom set configurations, alternative tap or instrument sizing, or private-label branding is available within the same ISO 13485-certified framework. Free shipping applies on orders of $99 or more.