Spinal Pedicle Screw Set 6mm – Polyaxial Thoracolumbar Fixation System with Complete Instrument Kit

The Spinal Pedicle Screw Set 6mm with Complete Instrument Kit is a comprehensive 6.0mm outer-diameter posterior spinal fixation system comprising polyaxial pedicle screws, titanium or stainless steel connecting rods, cross-link connectors, and the full instrument set required for screw placement, rod contouring, compression, distraction, and final construct locking, all organized in a dedicated instrument case. The 6.0mm screw diameter is the standard workhorse size for thoracolumbar posterior instrumented fusion in adult patients with normal to robust pedicle dimensions at T10–L5, covering the most common spinal segments addressed in degenerative disc disease, spondylolisthesis, spinal stenosis, kyphotic deformity correction, traumatic fracture stabilization, and metastatic spinal disease. The polyaxial screw head allows multi-directional rod seating, compensating for the three-dimensional variability in pedicle screw trajectory between adjacent vertebral levels without requiring rod re-contouring. It is used by spine surgeons, neurosurgeons, and orthopedic spinal specialists in hospital operating rooms, spine surgery centers, and tertiary neurosurgical facilities. Sold as 1 complete set.

6.0mm Polyaxial Pedicle Screw Design: Trajectory Compensation and Load-Sharing Fixation

The 6.0mm pedicle screw is dimensioned to engage the full cross-sectional width of the thoracolumbar pedicle in adults, providing three-zone purchase — cortical pedicle wall engagement, cancellous vertebral body purchase, and bicortical engagement when required — that distributes pullout load across the trabecular bone of the vertebral body rather than concentrating it at the pedicle cortex. The polyaxial screw head is the defining feature of contemporary pedicle screw systems: the inner screw head is articulated within the outer tulip receiver on a spherical bearing surface, allowing the surgeon to insert each screw along its optimal pedicle trajectory — which varies by level, laterality, and patient anatomy — and then capture the connecting rod regardless of the angular offset between adjacent screws in the construct. This eliminates the requirement for precise screw-to-screw angular alignment that made monoaxial screw systems technically demanding, and reduces intraoperative rod bending time. The saddle or U-groove receiver accepts standard 5.5mm, 6.0mm, or 6.35mm diameter rods depending on the specific system configuration, and the top-loading set screw mechanism locks the rod in the tulip under measured torque to complete the construct. The cannulated versions included in this set allow Kirschner wire or guide pin-assisted placement under fluoroscopic guidance using the Jamshidi technique — the standard percutaneous or minimally invasive pedicle screw insertion method at thoracolumbar levels.

Surgical Application: Posterior Thoracolumbar Instrumented Fusion and Stabilization

The 6.0mm pedicle screw system is indicated across the full range of posterior thoracolumbar spinal fusion and stabilization procedures in adult patients. In degenerative lumbar surgery, the primary application is posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) at one or multiple levels for spondylolisthesis, degenerative disc disease with instability, or post-discectomy instability, where pedicle screw-rod fixation provides the mechanical stability needed for interbody graft consolidation and segmental fusion. In adult spinal deformity, 6.0mm screws are used at the thoracolumbar junction and lumbar levels as part of long-segment posterior constructs for fixed sagittal imbalance, adult degenerative scoliosis, and revision fusion, with the polyaxial head accommodating the varied screw trajectories across multiple levels in a complex construct. In spinal trauma, the system stabilizes thoracolumbar burst fractures, fracture-dislocations, and distraction injuries across short or long segments, with compression and distraction maneuvers performed using the instruments in this set prior to final rod locking. For metastatic spinal disease with instability or epidural cord compression, the system enables circumferential stabilization following decompressive laminectomy without requiring anterior approach. The complete instrument kit provides every tool required for screw placement, rod reduction into the tulip heads, cross-link application, and construct finalization within a single organized case.

Complete Instrument Kit: Pedicle Preparation Through Construct Locking

The instrument set accompanying the 6.0mm pedicle screws covers all operative phases of posterior spinal fixation. Pedicle access instruments — including a pedicle awl or gear-shift probe for cortical entry at the pedicle isthmus, a pedicle finder or ball-tipped probe for canal wall palpation during pedicle channel creation, and a pedicle tap sized for 6.0mm screw thread preparation — establish the screw path and confirm four-wall cortical integrity before screw insertion. The screw driver assembly accepts the polyaxial screw head and delivers controlled torque for bicortical or unicortical engagement. Rod-holding forceps and a French bender or rod bender provide intraoperative rod contouring to match the patient's sagittal and coronal profile within the construct. Reduction instruments — including a persuader or rod pusher, a reduction tower, and compression-distraction pliers — allow the surgeon to apply segmental compression across a fusion site, achieve distraction for fracture reduction or disc height restoration, and seat a pre-contoured rod into tulip heads that are not co-planar due to screw trajectory variability. Set screw drivers and a final torque wrench deliver the manufacturer-specified locking torque to each polyaxial set screw without over-tightening and stripping the tulip threads. The cross-link connectors and their insertion instruments stiffen the bilateral rod construct in the transverse plane, an important addition in long-segment deformity constructs where construct width determines rotational rigidity. All instruments are organized in a dedicated labelled case for sterile field count and post-operative set audit.

Material, Construction, and Implant Integrity

The pedicle screws, rods, and connectors in this system are manufactured from surgical-grade stainless steel or titanium alloy, both of which meet the biocompatibility, yield strength, and fatigue resistance requirements for long-term posterior spinal implants under cyclical loading during the fusion consolidation period. Titanium alloy (Ti-6Al-4V) offers reduced artifact generation on post-operative MRI and CT compared to stainless steel, supporting intraoperative neuromonitoring and post-operative imaging of the neural canal and adjacent soft tissues — a significant clinical advantage in revision surgery and deformity cases requiring repeated post-operative assessment. Stainless steel variants provide higher absolute strength and are preferred in some high-load constructs. The polyaxial articulation in the screw head uses a design that maintains full angular freedom during rod insertion and locks definitively under set screw torque without residual micromotion. All instruments are manufactured from stainless steel and sized for the 6.0mm screw system torque and leverage requirements, ensuring that force application during pedicle preparation and rod reduction remains within the safe range for pedicle wall integrity at thoracolumbar levels.

CE Mark, ISO 13485, and FDA Certification for Spinal Implant Procurement

The Spinal Pedicle Screw Set 6mm with Complete Instrument Kit is manufactured under a quality management system certified to ISO 13485, governing all production stages from raw material procurement through precision machining, implant finishing, dimensional inspection, sterile packaging, and lot-level traceability. CE Mark certification confirms conformity with European Medical Device Regulation requirements for Class III spinal fixation implants and associated surgical instruments distributed within EU and associated regulatory territories. FDA compliance documentation is maintained for United States distribution, satisfying the regulatory requirements applicable to pedicle screw systems procured by US hospitals, spine surgery centers, and group purchasing organizations operating under applicable IDE or 510(k) clearance frameworks. These three certifications together satisfy the procurement and tender documentation requirements of institutional buyers in the USA, India, Pakistan, Vietnam, and across major international tender frameworks. Biocompatibility documentation, material certificates, clinical data summaries, and certificates of conformity are available upon request for vendor qualification and tender submissions. OEM and custom system configurations are available within the same certified manufacturing environment.

Product Specifications

Frequently Asked Questions

What procedures is the Spinal Pedicle Screw Set 6mm designed for?
The 6.0mm pedicle screw system with complete instrument kit is designed for posterior thoracolumbar spinal fixation and instrumented fusion across the full range of adult spinal surgery indications. The primary application is posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) for degenerative spondylolisthesis, instability, and adjacent segment disease at L1–L5, where bilateral pedicle screw-rod fixation provides the segmental stability required for interbody graft fusion. Additional indications include long-segment posterior fixation for adult spinal deformity including degenerative scoliosis and fixed sagittal imbalance, short-segment stabilization of thoracolumbar burst fractures and fracture-dislocations in trauma surgery, and palliative stabilization of metastatic spinal disease causing instability or neurological compromise. The 6.0mm outer diameter is appropriate for adult thoracolumbar pedicles with inner diameters of approximately 5mm or greater, which encompasses the majority of patients at T10–L5 on pre-operative CT measurement. The polyaxial head design accommodates the trajectory variability between adjacent screws, eliminating the need for precise screw-to-screw angular alignment and significantly reducing intraoperative rod bending time compared to monoaxial systems. The complete instrument kit provides every tool from pedicle entry through construct locking within a single organized case.

What is included in the complete instrument kit and what does each component do?
A complete 6.0mm pedicle screw instrument kit typically includes the following functional groups. Pedicle access and preparation instruments — the pedicle awl for cortical entry at the pedicle isthmus under tactile feedback, the pedicle probe or gear-shift for channel creation through the pedicle and into the vertebral body, the ball-tipped probe for four-wall palpation to confirm the channel does not breach the medial, lateral, superior, or inferior pedicle cortex, and a 6.0mm pedicle tap for thread preparation in harder cortical bone. Screw insertion instruments — the torque-limiting screw driver sized for the 6.0mm polyaxial head, allowing controlled insertion torque without stripping the pedicle. Rod instrumentation — rod holders, a French bender or rod bender for in-situ sagittal and coronal contouring, and a rod cutter. Reduction and construct assembly instruments — the rod reduction tower or persuader for seating a pre-contoured rod into tulip heads that are not perfectly co-planar, and compression-distraction pliers for applying segmental forces within the construct before final locking. Locking instruments — a set screw holder and final torque wrench for delivering the specified locking torque to each polyaxial saddle set screw. Cross-link instruments for transverse connector application. The perforated storage case maintains all instruments in a labelled, organized layout for intraoperative count verification. Verify the specific instrument manifest for this set against the case label or Shopify admin record.

Why is 6.0mm the most common pedicle screw diameter for thoracolumbar fusion, and when are other sizes used?
The 6.0mm outer diameter represents the intersection of maximum pedicle engagement and minimum pedicle wall breach risk across the adult thoracolumbar population. At L3–L5, the average inner pedicle diameter in adults is 9–14mm, meaning a 6.0mm screw occupies approximately 40–65% of the pedicle cross-section — sufficient for cortical wall engagement and vertebral body purchase without risking medial wall breach. At T10–T12 and L1–L2, where pedicle inner diameters narrow to 6–9mm in many patients, a 6.0mm screw remains within safe limits for the majority of adult patients. Smaller 4.5mm and 5.0mm screws are used in smaller or more osteoporotic patients, at thoracic levels T2–T9 where pedicles narrow further, and in adolescent deformity correction. Larger 7.0mm and 8.0mm screws are reserved for L4–S1 in larger patients or for revision fixation where increased pullout resistance is required. The 6.0mm system therefore provides the broadest clinical applicability across thoracolumbar instrumentation, which is why it is the default diameter stocked in most spine surgery centers and why a 6.0mm complete set is the anchor instrument system in a functional spine fixation inventory.

What sterilization methods are compatible with the instruments in this set?
The stainless steel instruments in the complete instrument kit are compatible with steam autoclave sterilization at standard pre-vacuum cycle parameters of 134°C / 273°F, which is the recommended primary reprocessing method for routine hospital use. The perforated instrument case is designed to permit steam and sterilant penetration to all instrument surfaces and should be confirmed as autoclave-compatible with the facility's sterilization equipment before direct processing. Ethylene oxide and hydrogen peroxide plasma sterilization are compatible with the stainless steel instruments for facilities with low-temperature sterilization protocols. The pedicle probe tips, screw driver coupling surfaces, and rod bender contact surfaces require particular attention during pre-cleaning to remove bone debris, cancellous material, and blood from instrument recesses before terminal sterilization. The pedicle tap should be inspected for thread wear and dimensional integrity at each reprocessing cycle, as tap thread wear increases the risk of premature thread engagement failure and pedicle wall breach during preparation. The implants — screws, rods, and connectors — are single-use devices and must not be resterilized after any contact with the sterile field or implantation.

What regulatory certifications does this spinal implant system carry?
The Spinal Pedicle Screw Set 6mm is manufactured under an ISO 13485-certified quality management system covering all production stages including raw material sourcing, precision machining, surface treatment, dimensional inspection, lot-level traceability, and packaging. CE Mark certification confirms conformity with European Medical Device Regulation requirements applicable to Class III spinal fixation implants and their associated surgical instruments. FDA compliance documentation is maintained for the United States market, meeting the regulatory requirements for pedicle screw systems supplied to US hospitals and surgical centers. These three certifications are recognized by institutional procurement offices in the USA, India, Pakistan, Vietnam, and across international tender frameworks. Biocompatibility documentation, material test certificates, dimensional inspection records, and full certificates of conformity are available on request for vendor qualification and institutional tender submissions.

Are bulk, institutional, or OEM orders available for this spinal implant set?
Yes. Peak Surgicals accepts institutional purchase orders for the Spinal Pedicle Screw Set 6mm with a minimum order quantity of 1 set, and volume pricing is available for hospitals, spine surgery centers, medical device distributors, and group purchasing organizations. Individual screw length and rod length replenishment orders are accepted for facilities that wish to restock specific depleted configurations within the system without purchasing a complete new kit. OEM manufacturing is available for buyers requiring private-label branding, modified screw diameter ranges — for example, a mixed-diameter set incorporating 5.5mm, 6.0mm, and 6.5mm screws — or alternative rod diameters and lengths adapted to specific fusion construct requirements, all produced within the same ISO 13485-certified manufacturing framework with full regulatory documentation. This set qualifies for free shipping on orders of $99 or more. Contact Peak Surgicals directly to discuss volume pricing, lead times, individual component orders, and OEM program requirements.