The Pedicle Screw System represents the gold standard in posterior spinal instrumentation, designed to achieve rigid segment immobilization across the thoracic, lumbar, and sacral spine. Used extensively in treating degenerative disc disease, spondylolisthesis, spinal trauma, spinal tumors, and complex scoliosis deformities, the mechanical stability of pedicle screw fixation directly determines bone graft fusion success rates.
At Remak Ortho Pvt Ltd, our spinal hardware is manufactured under stringent ISO 13485:2016, CE, and Indian FDA approval frameworks. Every pedicle screw is micro-machined from medical-grade raw materials—primarily Titanium Grade 5 (Ti-6Al-4V ELI - Extra Low Interstitial) and Stainless Steel 316L / SS LVM—using advanced CNC Swiss-type sliding head turning lathes. This ensures microscopic thread perfection, high fatigue resistance under cyclic spinal loading, and absolute dimensional consistency.
The pullout strength of a pedicle screw is influenced by its thread pitch, outer-to-inner diameter ratio, insertion torque profile, and bone density. Remak Ortho pedicle screws utilize a dual-thread (quad-lead) architecture. The proximal region features a finer thread pitch designed to grip cortical bone at the pedicle walls, while the distal region transitions into a deeper, coarser thread profile optimized for cancellous bone within the vertebral body. This dual-geometry increases pullout resistance by up to 34% compared to conventional single-thread designs, drastically reducing the risk of implant loosening in osteopenic patients.
| Parameter / Feature | Monoaxial Pedicle Screws | Polyaxial Pedicle Screws | Cannulated MIS Pedicle Screws | Reduction Pedicle Screws |
|---|---|---|---|---|
| Primary Application | Trauma & Heavy Deformity Correction | Degenerative Lumbar & Multilevel Fusion | Minimally Invasive Spine Surgery (MIS) | Spondylolisthesis & Severe Scoliosis |
| Angular Articulation | Rigid (0° Flexion) | ±25° to ±30° Multi-directional Cone | ±25° Polyaxial Articulation | Extended Break-away Tabs (20-30mm) |
| Available Diameters | 4.5mm, 5.5mm, 6.5mm, 7.5mm | 4.5mm, 5.5mm, 6.5mm, 7.5mm, 8.5mm | 5.5mm, 6.5mm, 7.5mm | 5.5mm, 6.5mm, 7.5mm |
| Available Lengths | 25mm to 55mm (5mm increments) | 25mm to 60mm (5mm increments) | 30mm to 55mm (5mm increments) | 35mm to 55mm (5mm increments) |
| Material Options | Ti-6Al-4V ELI / SS 316L / SS LVM | Ti-6Al-4V ELI (Grade 5 ASTM F136) | Ti-6Al-4V ELI (Grade 5 ASTM F136) | Ti-6Al-4V ELI (Grade 5 ASTM F136) |
| Rod Compatibility | Ø 5.5mm / Ø 6.0mm Titanium Rods | Ø 5.5mm / Ø 6.0mm Titanium Rods | Ø 5.5mm Pre-curved / Straight Rods | Ø 5.5mm / Ø 6.0mm Titanium Rods |
| Locking Mechanism | Square-thread Anti-cross-threading Set Screw | Buttress / Square Thread Set Screw | Internal Hex Drive Set Screw | Break-off Top Extension Set Screw |
Selecting the optimal alloy grade is vital for mechanical durability and radiological monitoring post-surgery:
Explore Remak Ortho's clinically proven posterior spinal fixation portfolio. Designed with ergonomic precision for optimal surgeon tactile feedback, smooth insertion torque, and rock-solid construct stability.
Features a 360-degree friction-fit swivel head allowing up to ±30° angular deviation in any plane. This facilitates effortless rod placement even across severe anatomical misalignments, drastically shortening operative time during multi-segment spinal fusion.
Comprehensive surgical sets equipped with silicone T-handle drivers, calibrated torque-limiting wrenches, pedicle probes, awls, reamers, and 3D rod benders. Manufactured from surgical-grade German stainless steel to endure rigorous autoclave sterilization cycles.
Engineered for percutaneous or minimally invasive spinal surgery. Features a hollow central lumen for precise guide-wire insertion over K-wires under C-arm fluoroscopy. Minimizes muscle disruption, blood loss, and post-operative recovery timelines.
Designed with temporary extended break-away collar tabs (25mm extension). Provides mechanical leverage to gradually pull slip-deformed vertebrae (spondylolisthesis) toward the contoured rod without applying excessive stress to the bone-screw interface.
The global spinal implants market is undergoing a rapid transition driven by demographic aging, expanding healthcare infrastructure in emerging economies, and technological breakthroughs in surgical navigation. As an OEM manufacturer and global exporter, Remak Ortho tracks these macroeconomic and technological shifts to keep our global procurement partners ahead of market demands.
Surgeons worldwide are favoring Minimally Invasive Spine (MIS) procedures over open surgeries to decrease infection rates and shorten hospital stays. Procurement managers must expand inventory of cannulated pedicle screw systems, specialized extenders, and radio-opaque markers designed for 3D intraoperative navigation.
Global medical buyers are mitigating geopolitical and inflationary risks by diversifying away from hyper-expensive European and North American OEM suppliers. Certified Indian manufacturers like Remak Ortho—offering ISO 13485 certification, CE markings, and FDA compliance—provide equivalent mechanical quality at 35%–50% more competitive cost structures.
Next-generation pedicle screws incorporate plasma-sprayed Hydroxyapatite (HA) or porous titanium coatings along the threaded shank. These surface treatments accelerate early osseointegration, providing critical anchoring security in geriatric patients with compromised bone mineral density.
With the integration of optical and electromagnetic navigation systems in modern operating rooms, pedicle screw instruments require tighter manufacturing tolerances (<0.01mm concentricity). Screws and drivers must feature standardized tracking array interfaces for seamless surgical robotic alignment.
Regulatory bodies are enforcing rigorous clinical evaluation, post-market surveillance (PMS), and Unique Device Identification (UDI) tracking. Distributors must partner exclusively with manufacturers who maintain comprehensive technical documentation master files (DMF) and full raw material traceability.
Hospitals are demanding streamlined, modular instrumentation trays that cover polyaxial, monoaxial, and cross-connector elements in unified sterilization boxes, optimizing OR turnaround times and reducing overall hospital inventory holding costs.
Remak Ortho Pvt Ltd operates a state-of-the-art medical device manufacturing hub in Ahmedabad, Gujarat, India. Our focus on engineering excellence, regulatory compliance, and client-centric OEM customization has established us as a reliable partner across 30+ countries worldwide.
Our production floor is equipped with high-precision multi-axis CNC Swiss-type sliding head turning centers, VMC milling units, and wire-cut EDM machinery. This infrastructure allows us to execute complex pedicle thread profiles, double-lead helices, and friction-fit polyaxial sockets with zero variance.
We source certified medical-grade Titanium (Grade 5 / Ti-6Al-4V ELI) and Stainless Steel (SS 316L / SS LVM) exclusively from accredited global mills. Every shipment includes chemical composition reports and mechanical pull/shear strength certificates for total traceability.
Our quality management system is fully accredited under ISO 13485:2016, Indian FDA (CDSCO), and CE guidelines. Every pedicle screw undergoes 100% optical comparator inspection, coordinate measuring machine (CMM) dimensional validation, and automated cleaning in ultrasonic passivating baths.
We offer global distributors complete custom manufacturing services—including custom screw geometry development, specialized color anodization (gold, blue, green, purple), laser marking with custom branding/UDI barcodes, and sterile/non-sterile blister packaging.
Below are detailed answers to the most common technical, regulatory, and procurement questions asked by medical device purchasing agents, hospital administrators, and orthopedic importers.
Monoaxial Pedicle Screws feature a fixed head orientation rigid to the threaded shank. They provide maximum mechanical rigidity, making them ideal for acute spinal trauma and severe deformity correction (scoliosis/kyphosis) where strong force application is required to align vertebrae.
Polyaxial Pedicle Screws feature a spherical head enclosed in a tulip collar, offering 360-degree swivel articulation up to ±30 degrees. This flexibility significantly eases rod engagement across multi-level fusion constructs, reducing operative time and intraoperative stress on adjacent bone tissue.
Cannulated Pedicle Screws contain a hollow central channel designed for Minimally Invasive Spine (MIS) surgery. They are passed over a guide wire (K-wire) placed via percutaneous puncture under fluoroscopic image guidance, preserving paraspinal muscle integrity and speeding post-operative healing.
Titanium Grade 5 (Ti-6Al-4V ELI, ASTM F136) is the material of choice for permanent spinal hardware due to three key advantages:
Set screw loosening or cross-threading during torque application is a major surgical complication. Remak Ortho addresses this through precision engineering:
Every shipment of Remak Ortho Pedicle Screw Systems includes a full regulatory compliance package:
Remak Ortho provides flexible procurement conditions for global importers and brand owners. Our standard non-sterile catalog implants typically carry a low initial MOQ (50 to 100 units per size specification), while custom OEM private label production runs depend on laser etching and packaging needs. Standard lead time for catalog orders ranges from 2 to 4 weeks, while custom OEM production schedules are delivered within 4 to 6 weeks. Express air freight options are available worldwide.
Our standard instrumentation sets are designed around universal connection interfaces (e.g., standard AO quick-coupling drives, hex drives, and standard 5.5mm / 6.0mm rod dimensions). For specialized contract manufacturing clients, we offer custom instrumentation design to ensure 100% cross-compatibility with existing proprietary implant geometry.
To combat fixation failure in osteopenic and osteoporotic spine cases, Remak Ortho offers specialized extended-diameter options (up to 8.5mm), tapered inner core geometries that compress surrounding bone during insertion, and cannulated screws engineered with side fenestrations for polymethylmethacrylate (PMMA) bone cement augmentation.
