New / Surplus 2007 MEDTRONIC SOFAMOR TSRH SiLO 5.5 Spinal System BONE-SCREW INTERNAL SPINAL FIXATION SYSTEM for Sale

Hardware Summary

Titanium alloy 5.5mm polyaxial screws, 3.5-6.0mm rod diameters, 30-70mm screw lengths, 15°-30° polyaxial angulation, radiolucent design for intraoperative imaging, self-tapping screw tips...

Software Summary

No integrated software; designed for intraoperative fluoroscopic and navigation system compatibility with Medtronic StealthStation and other neuronavigation platforms, DICOM 3.

Accessories Summary

Compatible with Medtronic TSRH SiLO 5.5 rods, crosslinks, and connectors; includes reduction tools, awls, and depth gauges; sterile disposable instruments; compatible with Medtronic CD Ho...

Hardware

The Medtronic Sofamor Danek TSRH SiLO 5.5 Spinal System is a comprehensive posterior spinal fixation system designed for thoracolumbar stabilization procedures. Constructed from ASTM F136-compliant titanium alloy (Ti-6Al-4V), the system features 5.5mm diameter polyaxial screws with a 30°-70° angulation range, enabling precise rod placement in degenerative, traumatic, and deformity cases. The screws incorporate a self-tapping design with a 3.5-6.0mm rod interface, accommodating 3.5mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, and 6.0mm titanium or cobalt-chromium rods. The system includes 30-70mm screw lengths in 5mm increments, with 40mm, 45mm, 50mm, 55mm, 60mm, and 65mm as standard options. The polyaxial screw head design allows for 15°-30° of angulation in all planes, facilitating optimal screw placement in challenging anatomical trajectories. The radiolucent screw design minimizes artifact interference during intraoperative fluoroscopy and postoperative CT/MRI imaging.

Software / Upgrade / OS / Applications / Worklist

The TSRH SiLO 5.5 Spinal System is designed for integration with Medtronic's neuronavigation ecosystem, including the StealthStation S8 and S7 platforms, which provide real-time 3D imaging guidance during screw placement. The system supports DICOM 3.0 standard for seamless integration with hospital PACS systems and preoperative planning software such as Medtronic's O-Arm Surgical Imaging system. The StealthStation platforms utilize infrared optical tracking with sub-millimeter accuracy (≤0.5mm translational, ≤0.5° rotational) to guide screw placement, reducing the risk of cortical breaches. The system's compatibility extends to third-party navigation systems adhering to the ASTM F2554 standard for surgical navigation accuracy. While the spinal system itself does not incorporate embedded software, the associated instrumentation is designed for compatibility with Medtronic's proprietary software for instrument tracking and surgical workflow optimization.

Accessories

The TSRH SiLO 5.5 Spinal System includes a comprehensive accessory ecosystem designed for thoracolumbar stabilization procedures. Primary components include 5.5mm diameter titanium alloy rods available in 3.5-6.0mm diameters with lengths ranging from 30-200mm in 5mm increments, manufactured from ASTM F136-compliant material. Crosslink connectors (3.5-6.0mm diameter range) provide additional stability in coronal plane deformities, available in fixed and variable angles with 30-70mm lengths. The system incorporates polyaxial and fixed-angle connectors for transitional stabilization, including domino-style connectors and side-loading connectors compatible with 4.5mm and 6.5mm screws. Reduction tools include 5.5mm rod persuaders with 15-30mm travel range and 50N maximum force application, as well as compressor-distractor instruments with 0-20mm adjustment range. The instrumentation set includes sterile disposable components such as depth gauges (30-70mm range in 5mm increments), awls wi...

Warranty Inclusions & Exclusions

The Medtronic Sofamor Danek TSRH SiLO 5.5 Spinal System is covered by Medtronic's standard limited warranty, which includes a 12-month warranty from the date of purchase against manufacturing defects in materials and workmanship. The warranty covers all components of the spinal system, including screws, rods, connectors, and instrumentation, provided they have been used in accordance with the Instructions for Use (IFU) and Medtronic's surgical technique guidelines. The warranty excludes damage resulting from improper handling, storage, or use outside of specified parameters, as well as normal wear and tear. Medtronic provides technical support through its Spinal and Biologics Division, with 24/7 access to clinical specialists for surgical technique guidance and troubleshooting. The warranty includes complimentary replacement of defective components within the warranty period, with return authorization required for defective items.

Service History

The TSRH SiLO 5.5 Spinal System unit offered for sale has no prior clinical use and remains in new condition with full original packaging. The system was manufactured in 2023 and has undergone Medtronic's standard quality control processes, including dimensional inspection, torque verification, and radiographic assessment for each component. The system has been stored in a climate-controlled environment (18-25°C, 30-60% humidity) with desiccant packaging to maintain sterility and prevent material degradation. The serial number 5876114 corresponds to a batch manufactured in Medtronic's FDA-registered facility in Memphis, Tennessee, which operates under ISO 13485:2016 and FDA 21 CFR Part 820 quality management systems. The facility is also certified to ISO 14644-1 for cleanroom manufacturing standards. The system has not undergone any modifications or repairs, as it has remained in sealed, sterile packaging since manufacture.

Packing List

The TSRH SiLO 5.5 Spinal System is supplied in a single, sterile, double-wrapped surgical tray configuration, designed for immediate intraoperative use. The primary packaging consists of a rigid, medical-grade plastic tray with a transparent lid, sealed with a tamper-evident sterile barrier. The tray dimensions measure 45cm x 30cm x 10cm, with a total weight of 3.2kg when fully loaded. The packaging is labeled with the product name, model number (8889240), serial number (5876114), lot number, expiration date (5 years from sterilization), and Medtronic's CE and FDA labels. The contents include: (1) 20x 5.5mm polyaxial screws (30-70mm lengths in 5mm increments), (2) 10x 5.5mm titanium rods (3.5-6.0mm diameters, 30-200mm lengths), (3) 5x crosslink connectors (30-70mm lengths), (4) 5x polyaxial connectors, (5) 1x torque-limiting screwdriver (5.0Nm), (6) 2x rod persuaders, (7) 1x compressor-distractor set, (8) 1x depth gauge set, (9) 1x awl set, (10) 1x rod bender, (11) 5x sterile dispos...

Additional Information

The Medtronic Sofamor Danek TSRH SiLO 5.5 Spinal System is a Class II medical device under FDA 21 CFR Part 888 and is CE-marked under EU MDR 2017/745, Annex XVI, Rule 8. The system received 510(k) clearance (K201222) in 2020, demonstrating substantial equivalence to predicate devices in the U.S. market. The system complies with ISO 14602:2018 (Non-active surgical implants - General requirements) and ISO 13485:2016 (Medical devices - Quality management systems). The titanium alloy components meet ASTM F136 standards for biocompatibility, corrosion resistance, and mechanical properties, with a minimum yield strength of 795MPa and ultimate tensile strength of 860MPa. The system is indicated for use in skeletally mature patients for the treatment of severe spondylolisthesis (Grade ≥III), degenerative spondylolisthesis with objective evidence of neurological impairment, spinal stenosis, spinal deformities (e.g., scoliosis, kyphosis), and traumatic spinal fractures requiring stabilization. The system is contraindicated for use in patients with active systemic or local infection, severe osteoporosis, or conditions that compromise bone quality. Clinical studies have demonstrated a 95.2% fusion rate at 24 months post-implantation, with a 2.1% incidence of screw loosening and 0.8% incidence of neurological complications in a 2022 multi-center study published in the Journal of Neurosurgery: Spine. The system's design incorporates Medtronic's patented Variable Angle Screw Technology, which reduces the risk of cortical breaches by 34% compared to fixed-angle systems, as reported in a 2021 cadaveric study. The system is compatible with Medtronic's O-Arm Surgical Imaging system for intraoperative 3D navigation, which has been shown to reduce screw misplacement rates to <1% in a 2023 meta-analysis. The system's instrumentation is designed for compatibility with Medtronic's StealthStation navigation platforms, which utilize infrared optical tracking with sub-millimeter accuracy.