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INTRODUCTION

The XEN-21 Spine System features meticulously desigened and superbly crafted implants and instrumentation, which address wide range of indications demanding surgical stabilization of the spine. XEN-21 Spine System highly emphasizes on its biocompatibility as it comes in Medical Grade Titanium Ti-6AI-4V ELI and Stainless Steel 316LVM variants. XEN-21 system utilizes a low profile design that incorporates anatomic hooks, polyaxial screws, and a dual closure mechanism. The load sharing design of the 5mm Titanium Rod allows for proper tension bend principle to applied when used with proper anterior column support.
 
The system addresses a wide range of indications in spine surgery including:

· Spondylolisthesis
· Spine trauma
· Degenerative Disc Disease
· Reconstruction surgery in tumor and infection
· Correction of Spinal Deformities

The key characteristics of the system include:-

· Titanium Alloy/Stainless Steel variants to suit varying requirements and surgical situations.

· Posterior of Anterior use with the same Implant components and Instrumentation.

· Screws available in Monoaxial and Polyaxial versions with buttress threads and tapered core
  diameter for better strength.

· Reduction Screw with uniquely designed tabs permit controlled reduction of the spine. No bulky
  instruments required, increasing tactile feel and permitting direct vgisualization durting procedure.

· Aantomic Hooks are specifically desigened to ensure the best fit available.

· Cages for Degenerative Disc Disease and other reconstructive spinal surgeries.

· The Delivery system (Cases and trays) designed to make the system more user friendly.

· Direct Anchor Attachment-Rod is attached to screw or hook directly in line. This minimizes the
  moment arm and profile, and increases the strength.

· Dual Closure-positive expansion lock is most secure mechanism in the market. The system
  provides multiple points of contact on the rod. Closure mechanism provides footprint to apply
  enough torque to assure rod is seated in the implant.

· Universal anchor attachment- All components utilize the same attachment to the rod, minimizing   confusion and time.

· Top Loading - System components are all top loading, making application and attachment of the   rod more user friendly.





XEN-21 Monoaxial Screw
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Specially Machined Start Thread

Smooth Insertion of
Inner Screw / Outer Nut
Without a 'false start'
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Radius Screw Base
Reduces 'toggle' at
Bone-Screw Interface.
More stable construct
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Tapered Core Diameter
at Base of Screw Thread
Improved resistance to
bending / failure of screw
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Better Stability
Thread diameter is same through
the screw while core diameter
increases gradually.

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Cancellous
Buttress Thread

for Superior Pull-out Strength

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Inner and Outer Nut



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Hollow U-groove

Five-Point Contact between Screw
and Rod for superior
Construct Stability

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XEN-21 Polyaxial Screw
The XEN-21 polyaxial screw is designed to enable easy rod capture in difficult situations caused by convergent pedicles, especially the lower lumber region. Available in Titanium(Ti6Al4V) and stainless steel(316LVM), the articulated spherical head allows an inclination of 20 degrees and features the same universal top loading connector common to other components of the system.













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XEN-21 Spondylolisthesis Reduction screw

The XEN-21 Spondylolisthesis Reduction screw is designed to complement the XEN-21 Posterior Spinal stabilization implant range. Correction and stabilization of difficult anatomical variations, encountered in higher grades of spondylolisthesis and other such deformities is facilitated by this system. Removable Break-off tabs with internal threads allow the surgeon to approximate the spine to the desired profile and opt to retain the implant to enable posterior stabilization following the procedure.

This device enables the surgeon to:-

1 Eliminate the use of complex approximation devices.
2 Achieve controlled and gradual anatomical reduction of the
   deformity
3 Gain secure insertion of the posterior Rod, into the
   implant construct.


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Rod

The XEN-21 rod comes in pre-cut sizes with hexagonal edges for a better grip. With the rod positioner, who attach to the hex end of the rod positioner, which attaches to the hex end of the rod the rod can be held and rotated with excellent control.

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The transverse connector

The XEN-21 Standard Transverse Connector

The XEN-21 Standard Transverse Connector consists of two Connecting Blocks and a Connecting Rod working in a ‘side- Loading’ configuration. The transverse Connecting Rod may be pre-stressed by either compression or distraction to prevent the ‘parallelogram effect’ .

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Transverse Rod
Dia : 3 mm with standard length
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The XEN-21 Staple Washer


The four pronged XEN-21Staple Washer is used in conjunction with XEN-21 spine screw for anterior interbody fixation. The countersunk base of the washer ensures a low profile while enhancing the bone-screw interface.

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The XEN-21 SPINE HOOKS- Design criteria

The XEN-21 hook System is a rational with a highly selective range of morphologically designed, easy-to-select spinal hooks. All hooks designs and critical hook dimensions such as hook blade angles and hook throat depth are based on morphological evidence which evolved from a morphometric study of the thoracic and lumber spine


The XEN-21 Pedicle Hook

The XEN-21 pedicle Hook is designed to embrace the pedicle of the thoracic vertebra. The 8mm blade width prevents intrusion of the medial margin of the hook blade into the foramen. The 20 degrees blade width prevents intrusion of the medial margin of the hook blade into the foramen. The 20degrees hook-blade angle closely approximates the angle of the thoracic facet joint.


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The XEN-21 Supralaminar Hook

The XEN-21 Supralaminar Hook fits the sublaminar space when inserted from the superior laminar edge. The hook blade angle of 15 degrees is designed to closely approximate the cross sectional profile of the superior laminar border while the blade takes into account, the caudal slope of the laminae. The 5.5mm blade width minimizes intrusion into the spinal canal while allowing a pair of hook to be used at the same level.

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The XEN-21 Infralaminar Hook

The XEN-21 Infralaminar Hook fits the sublaminar space when inserted from the inferior laminar edge. The hook blade takes into account, the caudal slope of the laminae and makes an angle of 30 degrees with the vertical, closely approximating the inferior laminar border. The 5.5mm blade width minimizes intrusion into the spinal canal while allowing a pair of hooks to be used at the same level.

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The XEN-21 Transverse Process Hook(Left and Right)

The XEN-21 Transverse Process Hook blade fits around the superior border of the transverse process, anchoring into the costo-transverse ligament. The offset hook body enables easy connection to the longitudinal rod despite the lateral position of the blade.

 

   
XEN-21 Monoaxial screw
Dia.(mm) Len. (cm) St.Steel (316LVM)
Titanium
(Ti-6AI-4V ELI)
5.3 30 BX500.5330 BX510.5330
5.3 35 BX500.5335 BX510.5335
5.3 40 BX500.5340 BX510.5340
5.3 45 BX500.5345 BX510.5345
6.0 30 BX500.6030 BX510.6030
6.0 35 BX500.6035 BX510.6035
6.0 40 BX500.6040 BX510.6040
6.0 45 BX500.6045 BX510.6045


XEN-21 Polyaxial screw
Dia.(mm) Len. (cm) St.Steel (316LVM)
Titanium
(Ti-6AI-4V ELI)
5.3 30 BX501.5330 BX510.5330
5.3 35 BX501.5335 BX510.5335
5.3 40 BX500.5340 BX510.5340
5.3 45 BX500.5345 BX510.5345
6.0 30 BX500.6030 BX510.6030
6.0 35 BX500.6035 BX510.6035
6.0 40 BX500.6040 BX510.6040
6.0 45 BX500.6045 BX510.6045


XEN-21 Spondylolisthesis Reducton screw
Dia.(mm) Len. (cm) St.Steel (316LVM)
Titanium
(Ti-6AI-4V ELI)
5.3 30 BX501.5330 BX510.5330
5.3 35 BX501.5335 BX510.5335
5.3 40 BX500.5340 BX510.5340
5.3 45 BX500.5345 BX510.5345
6.0 30 BX500.6030 BX510.6030
6.0 35 BX500.6035 BX510.6035
6.0 40 BX500.6040 BX510.6040
6.0 45 BX500.6045 BX510.6045


XEN-21 Rod
Dia.(mm) Len. (cm) St.Steel (316LVM)
Titanium
(Ti-6AI-4V ELI)
5.0 50-150 BX600.5050-5150
with 10mm diff
BX610.5050-5150
with 10mm diff
5.0 200-400 BX600.5200-5400
with 50mm diff
BX610.5200-5400
with 50mm diff


XEN-21 Cage
Dia.(mm) Len. (cm) St.Steel (316LVM)
10.0 BX1700.1000 BX1710.1000
13.0 BX1700.1300 BX1710.1300
16.0 BX1700.1600 BX1710.1600
19.0 BX1700.1900 BX1710.1900


Description St.Steel
(316LVM)
Titanium
(Ti-6AI-4V ELI)
XEN-21 Inner Screw BX700.00 BX710.00
XEN-21 Outer Screw BX800.00 BX810.00
XEN-21 Block for Standard
Transverse Connector
BX900.00 BX910.00
XEN-21 Connectiong Rod 3mm for Standard Transverse Connector BX1000.00 BX1010.00
XEN-21 Staple BX1100.00 BX1110.00
XEN-21 Pedicle Hook BX1200.00 BX1210.00
XEN-21 Supra Laminar Hook BX1300.00 BX1310.00
XEN-21 Infra Laminar Hook BX1400.00 BX1410.00
XEN-21 Transverse Process Hook (Left) BX1500.00 BX1510.00
XEN-21 Transverse Process Hook (Right) BX1600.00 BX1610.00
 
 
 
 
 
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