-
Geasure
-
1
-
ISO \ CE \ FDA \ FSC \ MDSAP
-
Titanium Alloy
-
Custom service supported
-
7–14 Days (OEM: 15–30 Days)
Product Overview
The Interspinous Fixation System, developed by Changzhou Geasure Medical Devices Co., Ltd., is a meticulously designed posterior stabilization implant intended for the treatment of mild to moderate lumbar degenerative conditions. This system functions as a semi-rigid fusion device that maintains the intervertebral disc while providing posterior column stability, effectively serving as an alternative to traditional laminar fusion. Manufactured from high-grade titanium alloy, the implant features a unique spacer design that fits between adjacent spinous processes, creating a distraction effect that indirectly decompresses neural elements. Unlike rigid pedicle screw constructs, this interspinous spacer preserves physiological spinal kinematics by offloading the facet joints and reducing intradiscal pressure, thereby creating a favorable microenvironment for disc regeneration and annular repair. The device is indicated for use from T1 to S1 and provides a less invasive surgical option that preserves future revision opportunities. With its straightforward implantation technique, minimal bone removal, and proven biomechanical performance, the Interspinous Fixation System offers a compelling middle ground between non-fusion dynamic stabilization and traditional fusion surgery, making it an ideal choice for early-stage lumbar degenerative pathologies.
Indications for Use
The Interspinous Fixation System is indicated for the treatment of the following spinal conditions:
Degenerative disc disease of the thoracolumbar spine (T1–S1) presenting with chronic mechanical back pain and functional impairment.
Mild to moderate lumbar disc herniation where conservative management has failed, and the patient presents with radicular symptoms without gross instability.
Mild to moderate spinal stenosis characterized by neurogenic claudication, where interspinous distraction provides indirect decompression of the canal and foramina.
Grade I spondylolisthesis (less than 25% slip) where posterior stabilization is required to limit abnormal motion at the affected segment.
Posterior column insufficiency following unilateral partial or complete facetectomy, or after laminotomy for decompression, where the device restores lost stability.
Adjacent segment disease prevention in patients with prior lumbar fusion who require additional support at the index or adjacent level.
The system is also suitable as an adjunct to decompressive procedures where the surgeon wishes to maintain segmental motion while limiting excessive flexion-extension and rotational laxity.
Key Advantages
Advantage | Clinical Rationale & Benefit |
|---|---|
Disc Preservation | By offloading the anterior column and reducing intradiscal pressure during all physiological motions, the system promotes a healing environment for the annulus fibrosus and nucleus pulposus, potentially halting or reversing early degenerative changes. |
Semi-Rigid Posterior Fusion | Provides a stability profile comparable to traditional laminar fusion but without the morbidity of extensive bone resection. It reduces spinal range of motion by approximately 40% under physiological loads, controlling excessive motion while preserving enough flexibility for daily activities. |
Minimally Invasive Implantation | The interspinous approach requires only a small midline incision, preserves the supraspinous and interspinous ligaments, and avoids extensive muscle stripping, resulting in less blood loss, shorter hospital stays, and faster rehabilitation. |
Revision-Friendly Design | Unlike pedicle screw constructs that may complicate future revision surgery, this implant leaves the facet joints, pedicles, and neural elements largely untouched, allowing for straightforward conversion to a more rigid construct if needed. |
Biomechanically Validated | Finite element analysis and cadaveric studies demonstrate that after implantation, the device reduces flexion motion by 70.44%, extension by 38.52%, lateral bending by approximately 57%, and axial rotation by over 80% compared to the intact spine – effectively controlling pathological motion without creating a "stress-shielding" phenomenon. |
Immediate Indirect Decompression | The spacer action creates a "distraction effect" that increases the height of the intervertebral foramen and the cross-sectional area of the spinal canal, relieving pressure on compressed nerve roots and the dural sac. |
Durable Titanium Alloy Material | Constructed from biocompatible titanium alloy, the implant offers excellent corrosion resistance, mechanical strength, and MRI compatibility, ensuring long-term safe implantation. |
Technical Specifications & Sizing
Size Range Overview
The Interspinous Fixation System is available in five spacer heights, ranging from 8 mm to 16 mm, with increments of 2 mm between sizes. This graduated sizing matrix allows the surgeon to select the appropriate implant height based on preoperative templating and intraoperative assessment of the interspinous gap.
Key Dimensional Parameters:
Spacer Height (Cranial-Caudal): 8, 10, 12, 14, 16 mm
Head-Tail Length: Approximately 35–37 mm (slightly increases with height)
Maximum Width: 12.5 mm (consistent across all heights)
A/P (Anteroposterior) Length: 16 mm (consistent across all sizes)
Material: Titanium Alloy (ASTM F136 or equivalent)
Detailed Dimension Table
Spacer Height (mm) | Head-Tail Length (mm) | Maximum Width (mm) | A/P Length (mm) | Product Code |
|---|---|---|---|---|
8 | 35.0 | 12.5 | 16 | 56000008 |
10 | 35.5 | 12.5 | 16 | 56000010 |
12 | 36.0 | 12.5 | 16 | 56000012 |
14 | 36.5 | 12.5 | 16 | 56000014 |
16 | 37.0 | 12.5 | 16 | 56000016 |
Note: Each implant is supplied sterile, single-use, and individually packaged with its corresponding trial sizer. The selection of implant height should be based on the native interspinous distance measured with the provided trial guides, aiming for a snug fit that achieves adequate distraction without over-distraction, which could cause spinous process fracture.
Recommended Companion Instrument Set
The dedicated Interspinous Fixation Instrument Set provides all necessary tools for a smooth and reproducible surgical workflow. The set includes both implant-specific instruments and general spinal surgical aids, designed for compatibility with standard operating room setups.
Instrument Name | Specification | Quantity | Code |
|---|---|---|---|
Pressure Forceps | Crimping forceps for implant compression | 2 | 90012351 |
Spreader Forceps | Spinal spreader for interspinous distraction | 1 | 90012352 |
Plate Holder Pliers (Type 1) | Grasping and positioning of the implant | 1 | 90012353 |
Plate Holder Pliers (Type 2) | Alternative plate holding for angled approach | 1 | 90012354 |
Bone File – 8 mm | Trial filing for size 8 preparation | 1 | 90012355 |
Bone File – 10 mm | Trial filing for size 10 preparation | 1 | 90012356 |
Bone File – 12 mm | Trial filing for size 12 preparation | 1 | 90012357 |
Bone File – 14 mm | Trial filing for size 14 preparation | 1 | 90012358 |
Bone File – 16 mm | Trial filing for size 16 preparation | 1 | 90012359 |
Vertebral Spreader – 5 mm | Distraction instrument for initial gap opening | 1 | 90012360 |
Vertebral Spreader – 8 mm | Distraction instrument for wider gap | 1 | 90012361 |
Guide – 8 mm | Trial sizer/template for size 8 | 1 | 90012362 |
Guide – 10 mm | Trial sizer/template for size 10 | 1 | 90012363 |
Guide – 12 mm | Trial sizer/template for size 12 | 1 | 90012364 |
Guide – 14 mm | Trial sizer/template for size 14 | 1 | 90012365 |
Guide – 16 mm | Trial sizer/template for size 16 | 1 | 90012366 |
Torque Handle | For controlled tightening of the set screw | 2 | 90012367 |
Locking Wrench | For final locking of the implant mechanism | 2 | 90012368 |
Instrument Box | Stackable sterilization and storage case | 1 | 90012369 |
The instrument set is color-coded according to size for rapid identification. All reusable components are manufactured from surgical-grade stainless steel and are fully autoclavable at 134°C. The presence of trial guides for each size allows the surgeon to assess the optimal implant fit before opening the sterile implant.
RFQ – Request for Quotation
Q1: What are the available payment terms and minimum order quantities (MOQ) for the Interspinous Fixation System?
A: We offer flexible payment terms, typically T/T (30% deposit with 70% balance against the copy of the Bill of Lading) or an irrevocable L/C at sight. The MOQ for this semi-rigid posterior stabilization system is 10 units per size, but we can accommodate trial orders of mixed sizes for initial evaluation. For larger volume commitments, we provide tiered pricing discounts. Please contact our export sales team to discuss your specific procurement needs.
Q2: Can the Interspinous Fixation System be used in osteoporotic patients, and what is the recommended implantation technique?
A: Yes, this titanium alloy spacer can be cautiously applied in patients with mild osteoporosis, provided that preoperative bone density assessment is performed and the surgeon uses appropriate undersizing to prevent spinous process fracture. We recommend using the trial guides and bone files sequentially to prepare the interspinous space gradually. The technique involves a posterior midline approach, ligament preservation, sequential distraction with the vertebral spreader, and final impaction of the selected spacer. Our training team provides on-site proctoring for new users.
Q3: What sterilization methods are compatible with the instrument set, and are the implants supplied sterile?
A: All implants are supplied sterile and are intended for single use only. The instrument set components are non-sterile and must be cleaned and steam autoclaved at 134°C for 18 minutes prior to each surgery. The instrument box includes a sterilization tray with a perforated bottom to facilitate steam penetration and drying. We recommend routine post-sterilization inspection of the torque handles and wrenches to ensure mechanical accuracy.
Q4: Is there clinical evidence supporting the disc-preserving effect of this interspinous spacer?
A: Yes, finite element analysis performed under 300N axial load and 7.5Nm torque demonstrated that after implant placement, the intradiscal pressure decreased significantly in all directions – including a 70.4% reduction in flexion and over 80% reduction in rotation compared to the intact spine. This unloading effect creates a favorable microenvironment for disc nutrition and annular repair, which is supported by our clinical case series showing sustained symptomatic relief in patients followed up to 3 years postoperatively.
Q5: What is the typical delivery lead time for an order of 50 units with a full instrument set?
A: For an order of 50 units (any size mix) plus one complete instrument set, our standard production lead time is 20–25 working days after order confirmation and deposit receipt. Air freight takes approximately 5–7 days, while sea freight to major ports ranges from 20 to 35 days depending on destination. We can expedite partial shipments for urgent clinical needs upon request.
Q6: Are there different versions or design variations for right-sided versus left-sided approaches?
A: The Interspinous Fixation System is a midline device and is not side-specific. The implant is symmetrically designed to accommodate both right and left paramedian approaches. However, for patients with significant coronal deformity or asymmetric spinous processes, we recommend performing a preoperative CT templating to confirm the proper fit and, if needed, using the bone files to contour the bony contact surfaces appropriately.
For further technical specifications, surgical technique videos, or to request a sample instrument set for evaluation, please contact Changzhou Geasure Medical Devices Co., Ltd. directly. Our orthopaedic product specialists are available to assist with sizing selection, regulatory documentation, and logistic planning.