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WALLEN Anterior Cervical System

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1.WALEN Anterior Cervical System Product Specifications

11124 Anterior Cervical Plate


Product No. Holes Length
11124-(022-032) 4 22.5/25/27.5/30/32.5
11124-(135-147) 6 35/37.5/40/42.5/45/47.5
11124-(022-032) 8 50/52.5/55/57.5/60/62.5/65/70


11125 Vertebral Screw


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



11125 Vertebral Screw


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


11126 Revision Screw



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


2.WALEN Anterior Cervical System Product Features


Integrated Plate and Spacer Design (Zero-Profile or Low-Profile)

  • Zero-profile or near zero-profile design reduces the risk of soft tissue irritation and dysphagia.

  • The implant fits entirely within the disc space, minimizing anterior prominence.


Pre-assembled or Modular Plate Options

  • Modular or integrated options provide flexibility for surgeon preference.

  • Some systems include pre-assembled plates and screws, simplifying the implantation process.


Self-Tapping, Variable and Fixed Angle Screws

  • Offers both fixed-angle and variable-angle screws for controlled fixation and tailored biomechanical support.

  • Self-tapping screws reduce surgical steps and bone trauma.


Anti-Backout Screw Locking Mechanism

  • Secure locking mechanism prevents screw loosening or backing out over time, enhancing construct stability.


Titanium or PEEK Cage Options

  • Options for titanium (often 3D-printed porous for osteointegration) or PEEK cages (radiolucent with radiographic markers).

  • Both materials support bone fusion while allowing imaging compatibility.


Multiple Heights, Lordotic Angles, and Footprints

  • Available in a range of heights, footprints, and lordotic angles for personalized fit and sagittal alignment restoration.


Graft Window and Bone Fusion Support

  • Generous graft window for maximum bone graft volume.

  • Optimized design to promote bony fusion between vertebral bodies.


Streamlined Instrumentation

  • Ergonomic instruments designed for precise placement, minimal retraction, and reduced OR time.

  • Color-coded and intuitive tools aid intraoperative efficiency.


Regulatory Clearance

  • FDA-cleared and/or CE-marked, ensuring compliance with major regulatory bodies.




3.WALEN Anterior Cervical System Product Indications

The WALEN Anterior Cervical System is intended for anterior cervical interbody fusion procedures at one or more levels (typically C2–T1) in skeletally mature patients for the treatment of:


Degenerative Disc Disease (DDD)

  • Defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies.


Spondylosis

  • Includes cervical osteophytes, loss of disc height, and/or spinal canal narrowing due to degenerative changes.


Cervical Disc Herniation

  • For patients with symptomatic disc herniation causing nerve root or spinal cord compression.


Cervical Spinal Stenosis

  • Narrowing of the cervical spinal canal causing neurological symptoms.


Cervical Instability

  • Including trauma (e.g., minor fractures), post-surgical instability, or instability due to degenerative changes.


Failed Previous Fusion (Pseudoarthrosis)

  • Revision procedures where prior cervical fusion has failed to achieve solid arthrodesis.


Usage Requirements

  • To be used in conjunction with bone graft material to facilitate fusion.

  • The device is intended for single-use implantation.



4.WALEN Anterior Cervical System Product Download


locking copmression plate brochure.pdf


5. Waston Medical Factory video



6.Waston Factory Show


WPS拼图123



7.WALEN Anterior Cervical System Product 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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