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H7 Spinal I Internal Fixation System (Hard Channel Minimally Invasive)

H7 Spinal I Internal Fixation System is a hard-channel minimally invasive posterior spinal fixation system designed to provide stable segmental fixation while minimizing soft-tissue disruption.
  • H7

  • WASTON

  • 11278/11279/11280/11281/11282

  • Ti

  • 11278/11279/11280/11281/11282

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1.H7 Spinal I Internal Fixation System (Hard Channel Minimally Invasive) Product Specifications


11278 Mono-axial Screw


Product No. Dia.
Length
11278-(030-055) 5.0 30-55
11124-(135-147) 5.5 35/37.5/40/42.5/45/47.5
11124-(022-032) 6.0 50/52.5/55/57.5/60/62.5/65/70


11279 Poly-axial Screw


Product No. Dia
Length
11125-(012-018) 3.5 12/14/16/18


11280 Fixing Rod IV (φ5.5)


Product No. Dia
Length
11125-(112-118) 3.5 12/14/16/18


11281 Fixing Rod IV(φ5.5)


Product No. Dia
Length
11126-(012-018) 2.5 12/14/16/18


11282 Break-off Setscrew


Product No. Dia
Length
11126-(012-018) 2.5 12/14/16/18


1. Product Description (Clinical / Marketing)

H7 Spinal I Internal Fixation System is a hard-channel minimally invasive posterior spinal fixation system designed to provide stable segmental fixation while minimizing soft-tissue disruption.
The system combines percutaneous pedicle screw technology with a rigid working channel, enabling precise screw placement, efficient rod insertion, and reliable spinal stabilization through a minimally invasive approach.

By preserving paraspinal muscles and reducing surgical trauma, the H7 system supports faster recovery, reduced blood loss, and improved postoperative outcomes, while maintaining the biomechanical strength required for thoracolumbar fixation.


Key Clinical Value

  • Accurate fixation through a controlled hard-channel pathway

  • Reduced muscle injury compared with open posterior fixation

  • Optimized balance between minimally invasive access and construct rigidity

  • Designed for efficiency, reproducibility, and surgeon confidence



2. Technical Overview

2.1 System Components

  • Pedicle Screws

    • Cannulated or solid options

    • Multiple diameters and lengths

    • Polyaxial screw heads for alignment flexibility

  • Rods

    • Pre-contoured or straight

    • Titanium alloy for strength and biocompatibility

  • Hard Channel Working Sleeve

    • Rigid tubular access channel

    • Maintains a stable surgical corridor

    • Facilitates accurate screw placement and rod delivery

  • Set Screws / Locking Caps

    • Secure rod fixation

    • Anti-backout design

  • Instrumentation

    • Percutaneous guides and dilators

    • Rod inserters and reducers

    • Torque-limiting drivers



2.2 Indications for Use

The H7 Spinal I Internal Fixation System is indicated for posterior spinal fixation as an adjunct to fusion in skeletally mature patients with:

  • Degenerative disc disease

  • Lumbar or thoracolumbar instability

  • Spondylolisthesis (Grade I–II)

  • Spinal stenosis (with fusion)

  • Traumatic fractures (selected cases)

  • Deformity correction requiring short-segment fixation



2.3 Key Features

  • Hard-Channel Minimally Invasive Technique
    Ensures a fixed, controlled surgical pathway for accuracy and safety.

  • Polyaxial Screw Design
    Facilitates rod placement even in anatomically challenging cases.

  • Percutaneous Workflow
    Smaller incisions and reduced tissue damage.

  • High-Strength Materials
    Titanium alloy components ensure durability and MRI compatibility.



2.4 Clinical Advantages

  • Reduced intraoperative blood loss

  • Less postoperative pain

  • Lower infection risk

  • Shorter hospital stay

  • Faster patient mobilization

  • Comparable biomechanical stability to open fixation systems



3. Brochure / Website Copy

Headline

H7 Spinal I – Precision Fixation Through a Minimally Invasive Hard Channel

Subheadline

Reliable posterior spinal stabilization with reduced surgical trauma.


Body Copy

The H7 Spinal I Internal Fixation System is engineered to support modern minimally invasive spine surgery. Its rigid hard-channel design provides a stable working corridor, enabling surgeons to perform accurate pedicle screw fixation with confidence and efficiency.

By combining minimally invasive access with robust mechanical performance, the H7 system helps reduce tissue disruption while delivering the stability required for effective spinal fusion.

Key Benefits (Bullet Section)

  • Hard-channel controlled access

  • Minimally invasive posterior fixation

  • Polyaxial pedicle screws for alignment flexibility

  • Reduced muscle damage and blood loss

  • Streamlined instrumentation for surgical efficiency

Call to Action

Designed for surgeons. Built for stability. Optimized for recovery.



4. Regulatory-Style Summary (IFU / Non-Promotional)

Device Name

H7 Spinal I Internal Fixation System (Hard Channel Minimally Invasive)


Device Description

The H7 Spinal I Internal Fixation System is a posterior spinal fixation system consisting of pedicle screws, rods, set screws, and associated instrumentation. The system is intended to provide temporary stabilization of the spine to promote fusion.


Intended Use

The system is intended for posterior fixation of the thoracolumbar spine as an adjunct to spinal fusion procedures in skeletally mature patients.


Indications

  • Degenerative disc disease

  • Spinal instability

  • Spondylolisthesis

  • Trauma

  • Deformities requiring posterior fixation


Contraindications

  • Active infection

  • Severe osteoporosis

  • Allergy to implant materials

  • Inadequate bone quality or quantity

  • Patients unable to comply with postoperative instructions


Materials

  • Titanium alloy (Ti-6Al-4V or equivalent)


Warnings and Precautions

  • For use by trained spine surgeons only

  • Not intended for cervical spine use unless specified

  • Implant removal may be required after fusion

  • Improper use may result in implant failure or neurological injury


Sterilization

  • Provided sterile or non-sterile (refer to labeling)

  • Follow hospital sterilization protocols for non-sterile components



5. Comparison with Other Spinal Fixation Systems

Feature H7 Spinal I (Hard Channel MIS) Traditional Open Fixation Soft-Tube MIS Systems
Surgical Approach Minimally invasive, hard channel Open posterior Minimally invasive, soft channel
Muscle Preservation High Low Moderate
Stability During Access High (rigid channel) High Lower
Accuracy of Screw Placement High High Variable
Blood Loss Low High Low
Learning Curve Moderate Low Higher
Operating Time Reduced with experience Longer Variable
Postoperative Recovery Faster Slower Faster


Key Differentiator:
The hard-channel design offers greater control and stability than soft-tube systems while preserving the minimally invasive benefits not achievable with traditional open fixation.



If you’d like, I can next:

  • Convert this into a print-ready brochure (PDF layout text)

  • Adapt it for FDA 510(k) / CE MDR language

  • Shorten it for distributor catalogs

  • Create a surgeon-facing slide deck outline



4.H7 Spinal I Internal Fixation System (Hard Channel Minimally Invasive) Product Download


locking copmression plate brochure.pdf


5. Waston Medical Factory video



6.Waston Factory Show


WPS拼图123



7.H7 Spinal I Internal Fixation System (Hard Channel Minimally Invasive) FAQ


1. What is the WALEN Anterior Cervical System used for?

The WALEN system is used in anterior cervical discectomy and fusion (ACDF) procedures to treat conditions such as degenerative disc disease, herniated discs, cervical spondylosis, and instability between C2–T1 vertebrae.


2. What type of implant is the WALEN system?

It is a zero-profile or low-profile integrated interbody device with anterior screw fixation. It may include titanium or PEEK cage options, depending on the model.


3. How many levels can the WALEN system be used for?

It is typically indicated for one or two adjacent cervical levels (e.g., C3–C4, C5–C6). Some models may support up to three levels depending on regulatory approvals and surgeon assessment.


4. What materials are used in the WALEN implants?

  • Titanium alloy (Ti-6Al-4V) – for plate and screw components, or full implants in some versions.

  • PEEK (polyether ether ketone) – an option for radiolucent cages with embedded radiographic markers.


5. Are the screws fixed or variable angle?

The WALEN system offers both:

  • Fixed-angle screws for rigid stability.

  • Variable-angle screws (typically up to 15°–20°) to accommodate patient anatomy and facilitate optimal placement.


6. Does the system have a screw locking mechanism?

Yes. It features an anti-backout locking mechanism to prevent screw loosening after implantation, enhancing long-term construct stability.


7. What bone graft materials can be used with the system?

The WALEN cage includes a central graft window and is compatible with:

  • Autograft (preferred)

  • Allograft

  • Synthetic bone graft substitutes (as per surgeon preference and hospital protocol)


8. What are the available sizes and lordotic options?

  • Multiple heights, footprints, and lordotic angles (typically 6°, 8°, or 12°) are available to restore cervical alignment and accommodate patient anatomy.


9. Can the WALEN system be used in revision surgeries?

Yes, the system is indicated for revision procedures such as pseudoarthrosis or hardware failure from previous ACDF surgeries.


10. Is the WALEN system MRI-compatible?

Yes. All components are made from non-ferromagnetic materials, making the system MRI-conditional. Always verify with the specific product IFU for MRI safety labeling.


11. What regulatory approvals does the system have?

The WALEN Anterior Cervical System is:

  • FDA 510(k) cleared (U.S.)

  • CE marked (Europe), where applicable

  • May have additional regional registrations depending on market



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