Spinal Pedicle Screw System Set – Open Posterior Pedicle Screw-Rod Fixation

The Spinal Pedicle Screw System Set from Peak Surgicals (SKU: PS-OS-00300-109) is a 30-piece open posterior pedicle screw-rod instrumentation set in stainless steel for lumbar and thoracic spinal fusion, covering the complete workflow of pedicle channel assessment with a Feeler for Screw Channel Straight (PS-FSCS-001) and Bent (PS-FSCB-008), pedicle access with an AWL (PS-AWL-023), pedicle tapping with four taps φ4.0 (PS-T-003), φ5.5 (PS-T-004), φ6.0 (PS-T-006), and φ7.0 (PS-T-007), polyaxial and monoaxial screw insertion with dedicated screwdrivers (PS-SPS-013, PS-SMS-014), pedicle wall assessment with Pedicle Probe Straight (PS-PPS-021) and Bent (PS-PPB-022), rod contouring with a Rod Bender (PS-RB-026) and Trail Rod (PS-TR-015), rod seating with Rod Holding Forceps (PS-RHF-025), Rod Pushing Forceps (PS-RPF-028), and Rod Pusher (PS-RP-017), in-situ rod bending with an In-situ Bending Iron (PS-IBI-012), rod rotation with a Rod Twist (PS-RT-020), segmental alignment with a Parallel Spreader (PS-PS-018) and Parallel Compressor (PS-PC-019), crosslink fixation with a Crosslink Nut Holder Hex (PS-CNHH-011) and Screwdriver Hex 3.5mm for Crosslink Nut (PS-SHC-005), set screw management with a Screw Nut Holder Hex (PS-SNHH-010) and Hex Screwdriver for Screw Nut (PS-HSSN-002), screw cutter management with a Screw Cutter for Long Arm Screw (PS-SCLAS-009) and Counter Torque for Screw Cutter (PS-CTSC-027), a general Counter Torque (PS-CT-030), an Insert Device for Fixation Pin (PS-IDFP-016), and T-Handle (PS-TQC-024) and Straight Handle (PS-SHQC-029) Quick Couplings, all in an Aluminum Box (PS-AB-31). It is used by spine surgeons performing open posterior pedicle screw-rod fixation for lumbar and thoracic fusion, spondylolisthesis, fracture stabilisation, and deformity correction.

Open Posterior Pedicle Screw-Rod Fixation: Indications and Instrument Workflow

Posterior pedicle screw-rod fixation is the standard technique for posterior lumbar and thoracic spinal fusion. The pedicle screw is a transpedicular screw inserted from the posterior surface of the transverse process-pedicle junction through the pedicle canal and into the vertebral body, providing a three-column fixation point that is biomechanically superior to hook or wire fixation for resisting flexion, extension, axial rotation, and lateral bending forces across the instrumented segment. The rod connects pedicle screws at adjacent levels into a rigid or semi-rigid spinal construct, maintaining the corrected alignment during the fusion period. The Spinal Pedicle Screw System Set (PS-OS-00300-109) provides the complete open posterior instrumentation workflow: pedicle entry with the AWL, pedicle channel creation and wall assessment with the feelers and probes, tapping in four diameters for screw sizes from small thoracic through large lumbar and iliac, screw insertion with both polyaxial and monoaxial screwdriver geometries, rod contouring and in-situ adjustment, segmental compression and spreading, crosslink fixation, and set screw cutter management with dual counter torque instruments.

Pedicle Access and Channel Assessment: Feelers, AWL, Probes, and Four Taps

Safe pedicle screw insertion requires careful channel preparation and assessment before the screw is advanced. The AWL (PS-AWL-023) creates the initial cortical entry at the pedicle entry point under fluoroscopic guidance. The Feeler for Screw Channel Straight (PS-FSCS-001) and Bent (PS-FSCB-008) are then inserted into the pedicle channel and rotated to palpate all four cortical walls — medial, lateral, superior, and inferior — before tapping, detecting any cortical breach that would indicate spinal canal, transverse foramen, or adjacent disc proximity. The Pedicle Probe Straight (PS-PPS-021) and Bent (PS-PPB-022) perform a secondary post-tapping wall assessment before the screw is inserted. The four taps — φ4.0mm (PS-T-003) for small thoracic pedicles, φ5.5mm (PS-T-004) for standard lumbar pedicles, φ6.0mm (PS-T-006) for larger lumbar and L5-S1 pedicles, and φ7.0mm (PS-T-007) for maximum-diameter screws in the ilium or large pedicles — are driven by the T-Handle Quick Coupling (PS-TQC-024) and Straight Handle Quick Coupling (PS-SHQC-029).

Screw Insertion, Rod Management, and Alignment Instruments

The Screwdriver for Polyaxial Screw (PS-SPS-013) engages the polyaxial screw head geometry, and the Screwdriver for Monoaxial Screw (PS-SMS-014) engages the monoaxial geometry — both are needed for mixed monoaxial-polyaxial constructs used in deformity correction and spondylolisthesis reduction. The Trail Rod (PS-TR-015) measures the required rod length and curvature by bending it to the screw head positions before the definitive rod is contoured. The Rod Bender (PS-RB-026) contours the definitive rod ex situ. The In-situ Bending Iron (PS-IBI-012) adjusts the rod after seating without removal. The Rod Holding Forceps (PS-RHF-025) introduces the rod into the wound. The Rod Pushing Forceps (PS-RPF-028) and Rod Pusher (PS-RP-017) seat the rod into successive tulip heads. The Rod Twist (PS-RT-020) rotates the seated rod for coronal deformity correction. The Parallel Spreader (PS-PS-018) and Parallel Compressor (PS-PC-019) distract and compress between adjacent levels along the seated rod. The Crosslink Nut Holder Hex (PS-CNHH-011) and Screwdriver Hex 3.5mm (PS-SHC-005) install the crosslink connector. The Screw Cutter for Long Arm Screw (PS-SCLAS-009) and Counter Torque for Screw Cutter (PS-CTSC-027) trim extended tulip arms. The Counter Torque (PS-CT-030) stabilises the tulip during final set screw tightening. The Insert Device for Fixation Pin (PS-IDFP-016) manages fixation pin elements in certain screw head designs.

CE Mark, ISO 13485, and FDA Certification

The Spinal Pedicle Screw System Set is manufactured under CE Mark, ISO 13485, and FDA compliant quality standards. ISO 13485 certification confirms Peak Surgicals operates a documented quality management system covering design control, material traceability, and production consistency for spinal surgical instruments. CE Mark confirms conformity with European medical device regulations, and FDA compliance supports procurement for US-based hospitals, spine surgery centers, and neurosurgical departments.

Product Specifications

Frequently Asked Questions

What procedures is the Spinal Pedicle Screw System Set used for?
The Spinal Pedicle Screw System Set (PS-OS-00300-109) is used for open posterior pedicle screw-rod fixation of the lumbar and thoracic spine. Primary indications include lumbar spinal fusion for degenerative disc disease with instability, isthmic and degenerative spondylolisthesis, thoracolumbar fracture stabilisation, posterior deformity correction requiring instrumented fusion, and revision posterior fixation for failed prior instrumentation. The four tap sizes (φ4.0–7.0mm) cover screw diameters from small thoracic pedicles through large lumbar pedicles and iliac fixation. The dual polyaxial and monoaxial screwdrivers accommodate mixed constructs used in deformity correction. The set is configured for open surgery with full exposure of the pedicle entry points through a posterior midline or paraspinal approach.

How does this set (PS-OS-00300-109, $1,375.00) relate to the other pedicle screw sets on the same store?
Peak Surgicals offers five pedicle screw instrumentation sets. This Spinal Pedicle Screw System Set (PS-OS-00300-109, $1,375.00) contains a 30-instrument open posterior set with PS-prefix reference numbers. The Bone Tool Spine Pedicle Screw Set (PS-OS-00300-19, $1,538.90) and the Spinal Pedicle Screw Set 6.0mm (PS-OS-00300-70, $2,198.90) both contain a 31-instrument set with 2200-01xx reference numbers covering the same instrument categories. The Pedicle Screw System Instruments Set PS1700 (PS-OP-5799, $1,538.90) uses PS1700-series references and adds a Reduction Clamp and Rod Rotators for deformity correction. The Spinal Pedicle Screw Set 5.5mm (2200-13xx, $1,815.00) is configured for MIS percutaneous surgery with a Persuader, Fixation Pins, and Torque Wrench. Confirm instrument content with Peak Surgicals before ordering if you need to verify configuration differences between any two SKUs.

What is the role of the two Feelers for Screw Channel?
The Feeler for Screw Channel Straight (PS-FSCS-001) and Bent (PS-FSCB-008) assess the pedicle channel walls before tapping and screw insertion. After the awl and initial pedicle channel preparation, the feeler is inserted into the channel and rotated to contact all four cortical walls — medial, lateral, superior, inferior. The straight feeler is used for standard lumbar pedicle trajectories; the bent feeler reaches the more angulated trajectories used in thoracic pedicle screw placement. Detecting any cortical breach before the tap and screw are advanced prevents spinal canal violation (medial breach), transverse foramen entry (lateral breach), and nerve root or disc injury (superior or inferior breach). The Pedicle Probe Straight (PS-PPS-021) and Bent (PS-PPB-022) then repeat the wall assessment after tapping, confirming the tapped channel walls are intact before the definitive screw diameter is introduced.

What are the two Counter Torque instruments used for?
The Counter Torque for Screw Cutter (PS-CTSC-027) is paired with the Screw Cutter for Long Arm Screw (PS-SCLAS-009) — when the cutter shears the extended tulip arm of a pedicle screw, it generates a rotational force that the counter-torque restrains by engaging the tulip body, preventing rotation of the pedicle screw in the vertebral bone during the cutting operation. The general Counter Torque (PS-CT-030) stabilises the tulip body during final set screw tightening by the primary screwdrivers, preventing the tightening torque from transmitting through the pedicle screw to the surrounding bone and causing micro-motion at the screw-bone interface. Both functions require distinct engagement geometries matched to their respective operations.

What certifications does this set carry?
The Spinal Pedicle Screw System Set is manufactured under CE Mark, ISO 13485, and FDA compliant quality standards. ISO 13485 certification confirms Peak Surgicals operates a documented quality management system covering design control, material traceability, and manufacturing consistency for spinal surgical instruments. CE Mark confirms conformity with European medical device regulations, and FDA compliance supports procurement for US hospitals, spine surgery centers, and neurosurgical departments requiring verified regulatory documentation.