Anterior
`
`iknterolateral
`
`Lateral
`
`Vertebral Spacer—AR. Vertebral body
`replacement device intended for use in
`the thoracolumbar spine.
`
`
`
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`NUVASIVE 2016
`Medtronic v. NuVasive
`|PR2013-00506
`|PR2013-00507
`|PR2013-00508
`
`1
`
`NUVASIVE 2016
`Medtronic v. NuVasive
`IPR2013-00506
`IPR2013-00507
`IPR2013-00508
`
`

`

`Vertebral Spacer — AR
`
`
`
`Features
`
`— Biocompatible radiolucent polymer
`allows clear assessment of bony fusion
`— Convex superior and inferior surfaces
`enhance anatomical interface with
`
`vertebral endplates
`— Lordotic shape (8”) restores natural
`sagittal alignment
`— Design allows simultaneous
`distraction and implant insertion
`— Axial canal receives allograft to allow
`fusion to occur through the implant
`— Teeth on superior and inferior surfaces
`of implant are designed to provide
`secure engagement with adjacent
`vertebral bodies
`
`— Three styles accommodate varying
`surgical approaches: anterior,
`anterolateral and lateral
`
`— Three radiopaque marker pins enable
`radiographic visualization of implant
`position
`
`— Heights from 9 mm through 21 mm,
`in 2 mm increments
`— Axial footprint is 24 mm depth x
`
`30 mm width
`
`30 mm width
`
`
`
`
`..>
`
`
`
`For anterior insertion
`
`For anterolateral insertion
`
`Lordotic design
`
`— Conditions that may place excessive stresses on bone and
`implants, such as severe obesity or degenerative diseases,
`are relative contraindications. The decision whether to use
`
`these devices in such conditions must be made by the
`physician taking into account the risks versus the benefits
`to the patient.
`
`— Use of these implants is relatively contraindicated in patients
`whose activity, mental capacity, mental illness. alcoholism,
`drug abuse, occupation, or lifestyle may interfere with
`their ability to follow postoperative restrictions and who
`may place undue stresses on the implant during bony
`healing and may be a higher risk of implant failure.
`
`Indications
`
`The Vertebral Spacer is a vertebral body replacement device
`intended for use in the thoracolumbar spine (T1—L5) to
`replace a collapsed, damaged, or unstable vertebral body due
`to tumor or trauma (i.e., fracture). The Vertebral Spacer is
`intended to be used with Synthes supplemental internal fixation
`systems. e.g., ATLP, VentroFix, and USS (including Click'x).
`The interior of the spacer component of the Vertebral Spacer
`can be packed with bone. The Vertebral Spacers are designed
`to provide anterior spinal column support even in the absence
`of fusion for a prolonged period.
`
`Contraindications
`
`— Use of the Synthes Vertebral Spacer is contraindicated
`when there is active systemic infection, infection localized
`to the site of the proposed implantation, or when the patient
`has demonstrated allergy or foreign body sensitivity to any
`of the implant materials.
`
`— Severe osteoporosis may prevent adequate fixation and thus
`preclude the use of this or any other orthopaedic implant.
`
`* Height measured from top of teeth, as shovm
`
`
`Synthes Vertebral Spacer—AR
`
`2
`
`

`

`
`
`Material
`The Synthes Vertebral Spacer—AR is manufactured from a
`biocompatible radiolucent polymer* material which allows
`the surgeon to radiographically assess the presence of fusion
`in the segment in which the Vertebral Spacer—AR has been
`implanted. Radiopaque marker pins assist the surgeon in
`determining the exact position of the implant, both intraop—
`eratively and postoperatively. The modulus of elasticity of the
`polymer approximates that of human cortical bone, which
`enables adequate compression of autograft in and around
`the implant, allowing better stress distribution and proper
`load sharing.
`
`25.000
`
`E
`E 20,000
`E
`'a 15.000
`g
`5 10.000
`"E’
`2
`'3
`E
`
`5.000
`
`0
`
`Vertebrthpater
`
`“3"]!an Body
`
`Figure 1. Compressive Strength
`
`Testing
`Testing was conducted to show that the Vertebral Spacer—AR
`can withstand clinically relevant loads in the lumbar spine.
`The ultimate compressive load that a vertebral body can
`withstand is 8,000 N.‘ Test results show that the Vertebral
`
`Spacer—AR can withstand maximum compressive loads of
`over 25,000 N (see Figure 1). Additionally, the Vertebral
`Spacer—AR passed fatigue compression testing concluded
`at clinically relevant loads for ten million cycles?
`
`2
`"'
`E
`
`Testing was also conducted to ensure that the Vertebral
`Spacer—AR was capable of resisting expulsion at clinically
`relevant loads. The maximum shear force that the lumbar
`spine (human disc) can withstand is approximately 150 N?
`Test results show that the Vertebral SpaceriAR can withstand
`expulsion loads >700 N (see Figure 2).1
`
`100°
`
`30°
`
`600
`
`400
`
`zoo
`
`a
`
`-
`Human Di“
`
`MEL-Water
`
`Figure 2. Pushout Strength
`
`* Polyefl'lerefl'lerketone (PEEK)
`l. 0. Petey. “Fracture of the Vertebral Emblale in the lumbar Spine." Acra. Om‘mp. Stand. 1957; 25 (smpl).
`2. T612019 performed at the Mechanical Testing Laboratory, Synthes Spine, Wat Chester, PA Bench test results not necessarily indicative of clinical results.
`3. AA. white and MM. Panjabi. Cfim'cai Biameo‘lam'cs of flieSpr'ne. Philadelphia: ijpincott. William and Wilkins. 1990. 7, 9.
`
`
`Synthes
`
`3
`
`

`

`Vertebral Spacer — AR Implant Sets
`
`
`
`1 18.804
`
`Vertebral Spacer—AR Implant Set
`
`
`
`304.922
`
`Vertebral SpaceriAR Module Case
`
`Vertebral Spacers—AR, 2 ea.
`Anterior
`
`Anterolateral
`
`Height
`Height
`
`889.961
`9 mm
`889.971
`9 mm
`
`889.962
`11 mm
`889.972
`11 mm
`
`889.963
`13 mm
`889.973
`13 mm
`
`889.964
`15 mm
`889.974
`15 mm
`
`889.965
`17 mm
`889.975
`17 mm
`
`889.966
`19 mm
`889.976
`19 mm
`
`889.967
`21 mm
`889.977
`21 mm
`
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`
`01.801004 Vertebral Spacer—AR Lateral Implant Set
`
`305.011
`
`Vertebral SpaceriAR Lateral Module Case
`
`Vertebral Spacers—AR, 3 ea.
`Lateral
`
`889.901
`889.902
`889.903
`889.904
`889.905
`889.906
`889.907
`
`Height
`9 mm
`11 mm
`13 mm
`15 mm
`17 mm
`19 mm
`21 mm
`
`Note: For additional information, please refer to padtage insert.
`For detailed deaning and sterilization instmctions, please refer to
`hmjfussyn‘lheicom!Medical+Communiter|eaning+and+Sterilization_htm
`or to the below listed inserts, which will I]! included in the shipping container:
`— Proc3sing Synthfi Reusable Medical Devices—Instruments, Instrument Trays
`and Graphic Cases—DJ1305
`— Processing Noniterile Synthes Implants—D1804
`
`
`SYNTHES” 5W 5"”
`1302 Wrights lane East
`Wstcruster, PA 19330
`Spl”6 Telephone: (610) 719-5000
`To order: (800) 523-0322
`Fax: (610) 251-9056
`
`Sm‘cm’m'
`2566 Meadawpine Boulevard
`Mississauga. Ontario 15146139
`Telephone: {905) 567-0440
`To order: (800)668-1119
`Fax: {905} 567-3185
`
`wwsynttuscnm
`
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