Jump to:
CORUS™ Spinal System
CORUS™ Allograft Delivery Instrument
CAVUX® Cervical Cage-B, CAVUX® Cervical Cage-SB
CAVUX® Cervical Cervical Cage-T
CAVUX® Cervical Cervical Cage-L
ALLY™ Bone Screw
ALLY™ Bone Screw-L


CORUS™ Spinal System

From: LBL-PMT-011 Spinal System (DX-22-100) US IFU, Rev 16

Device Description
The CORUS Spinal System instruments are used to access and prepare the posterior cervical spine for joint fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of allograft or autograft in patients with or without anterior or posterior instrumentation. It is recommended that commercially available autograft or allograft be used to aid fusion. Autograft or allograft material is not supplied as part of the system.

INDICATIONS FOR USE:
The CORUS™ Spinal System is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

CONTRAINDICATIONS:
The CORUS Spinal System should not be used in any of the following instances:
— Absence of the pedicle, lateral mass, or facet joints at the segment to be fused.
— Allergy to any of the materials in the System.
— Pregnancy.
— Non-skeletally mature patients.

WARNINGS:
— Physicians using CORUS Spinal System should have significant experience and proper training in spinal surgery including spinal fusion.
— Do not clean, resterilize or reuse the CORUS Spinal System. Attempting to clean or resterilize disposable instruments may compromise the dimensional and mechanical integrity of the device and may lead to patient or user injury.
— Do not use disposable instruments that are deformed or damaged.
— Do not subject instruments to high loads or excessive impact as breakage may occur.

Return to top


CORUS™ Allograft Delivery Instrument

From: LBL-PMT-086 CORUS Allograft Delivery Instrument (PD-10-400) IFU, Rev 10

INTENDED USE AND INDICATIONS:
The CORUS™ Allograft Delivery Instrument is intended and indicated for the delivery of structural bone graft to a target area of the spine.

CONTRAINDICATIONS:
The CORUS™ Allograft Delivery Instrument should not be used in any of the following instances:
— Absence of the pedicle, lateral mass, or facet joints at the segment to be fused.
— Allergy to any of the materials in the System.
— Pregnancy.
— Non-skeletally mature patients.

WARNINGS:
— Physicians using CORUS Spinal System should have significant experience and proper training in spinal surgery including spinal fusion.
— Do not clean, resterilize or reuse the CORUS Spinal System. Attempting to clean or resterilize disposable instruments may compromise the dimensional and mechanical integrity of the device and may lead to patient or user injury.
— Do not use disposable instruments that are deformed or damaged.
— Do not subject instruments to high loads or excessive impact as breakage may occur.

Return to top


CAVUX® Cervical Cage-B, CAVUX® Cervical Cage-SB

From: LBL-PMT-045 CAVUX Cervical Cage-B, Cervical Cage-SB (PD-31-20X) IFU, Rev 8

DESCRIPTION:
CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.

INDICATIONS FOR USE:
The CAVUX® Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

CONTRAINDICATIONS:
Patients should be warned of these contraindications:
— Infection, local to operative site.
— Allergy to Titanium
— Stainless steel constructs, local to operative site.
— Local inflammation.
— Fever or leukocytosis.
— Pregnancy.
— Paget’s disease
— Renal Osteodystrophy
— Cancer of the spine;
— Advanced Diabetes;
— Obesity.
— Rheumatoid Arthritis;
— Rapid joint disease, bone absorption, osteopenia, poor bone quality, and/or osteoporosis.
— Grossly distorted anatomy due to congenital abnormalities.
— Any medical or surgical condition that would preclude the potential benefit of spinal implant surgery (i.e. elevation of white blood count (WBC) or marked left shift in the WBC differential count).
— Inadequate tissue coverage over surgical site.
— Case not needing autogenous bone graft, fusion, or fracture healing.
— Prior fusion at the level(s) to be treated.
— A patient unwilling or unable to comply with postoperative instructions.
— Any instance in which the implant would interfere with anatomical structures or expected physiological performances.

WARNINGS:
In any surgical procedure, the potential for complications exists. The risks and complications with these implants include but are not limited to:
— Infection or painful, swollen or inflamed implant site
— Fracture of the implant
— Loosening, bending, breaking or dislocation of the implant requiring revision surgery
— Bone resorption
— Bone over-production
— Allergic reaction(s) to implant material(s)
— Histological responses possibly involving macrophages and/or fibroblasts
— Migration of particle wear debris possibly resulting in a bodily response
— Embolism
— Subsidence of the device into the vertebral body.
— Bone loss and/or decrease in density due to stress shielding.
— Malalignment of anatomical structures (i.e. loss of normal spinal contours or change in height).
— Physiological reaction to implant devices due to foreign body intolerance including inflammation, local tissue reaction, and possible tumor formation.
— Loss of neurological function by several mechanisms, including direct compression by component parts, stretching of the spinal cord by component parts, vascular spinal cord compromise, or other mechanisms.

Return to top


CAVUX® Cervical Cervical Cage-T

From: LBL-PMT-037 CAVUX Cervical Cage-T (PD-31-100) IFU, Rev 9

DESCRIPTION:
CAVUX Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX Cervical Cages are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.

INDICATIONS FOR USE:
The CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

CONTRAINDICATIONS:
Patients should be warned of these contraindications:
— Infection, local to operative site
— Allergy to Titanium
— Stainless steel constructs, local to operative site
— Local inflammation
— Fever or leukocytosis
— Pregnancy
— Paget’s disease
— Renal Osteodystrophy
— Cancer of the spine
— Advanced Diabetes
— Obesity
— Rheumatoid Arthritis
— Any medical or surgical condition that would preclude the potential benefit of spinal implant surgery (i.e. elevation of white blood count (WBC) or marked left shift in the WBC differential count)
— Grossly distorted anatomy due to congenital abnormalities Grossly distorted anatomy due to congenital abnormalities
— Rapid joint disease, bone absorption, osteopenia, poor bone quality, and/or osteoporosis
— Inadequate tissue coverage over surgical site
— Case not needing autogenous bone graft, fusion, or fracture healing
— Prior fusion at the level(s) to be treated
— A patient unwilling or unable to comply with postoperative instructions
— Any instance in which the implant would interfere with anatomical structures or expected physiological performances

WARNINGS:
In any surgical procedure, the potential for complications exists. The risks and complications with these implants include but are not limited to:
— Infection or painful, swollen or inflamed implant site
— Fracture of the implant
— Loosening, bending, breaking or dislocation of the implant requiring revision surgery
— Bone resorption
— Bone over-production
— Allergic reaction(s) to implant material(s)
— Histological responses possibly involving macrophages and/or fibroblasts
— Migration of particle wear debris possibly resulting in a bodily response
— Embolism
— Subsidence of the device into the vertebral body
— Bone loss and/or decrease in density due to stress shielding.
— Malalignment of anatomical structures (i.e. loss of normal spinal contours or change in height)
— Physiological reaction to implant devices due to foreign body intolerance including inflammation, local tissue reaction, and possible tumor formation
— Loss of neurological function by several mechanisms, including direct compression by component parts, stretching of the spinal cord by component parts, vascular spinal cord compromise, or other mechanisms
— Adjacent Segment Disease (ASD)

Return to top


CAVUX® Cervical Cervical Cage-L

From: LBL-PMT-122 CAVUX Cervical Cage-L IFU (PD-31-6XX), Rev 5

DESCRIPTION:
CAVUX® Cervical Cage-L implants are titanium constructs offered in various heights. All CAVUX® Cervical Cage-L implants are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are provided sterile and are single-use only. Available size ranges are as follows:
Cage heights: 6mm to 10mm
Cage footprint: 12mmx15mm, 14mmx17mm
Cage lordotic angle: 7 degrees

INDICATIONS FOR USE:
CAVUX™ Cervical Cage-L with Supplemental Fixation:
The CAVUX® Cervical Cage-L is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

CAVUX® Cervical Cage-L Standalone Use:
When used in conjunction with ALLY™ Bone Screw-L, CAVUX Cervical Cage-L is indicated for standalone use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device.
CAVUX Cervical Cage-L is to be used with autogenous or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. CAVUX Cervical Cage-L must be used with ALLY Bone Screw-L while serving as a standalone system, and as such requires no additional supplementary fixation systems.

CONTRAINDICATIONS:
Patients should be warned of these contraindications:
— Infection, local to operative site.
— Allergy to Titanium
— Stainless steel constructs, local to operative site.
— Local inflammation.
— Fever or leukocytosis.
— Pregnancy.
— Paget’s disease
— Renal Osteodystrophy
— Cancer of the spine;
— Advanced Diabetes;
— Obesity.
— Rheumatoid Arthritis;
— Any medical or surgical condition that would preclude the potential benefit of spinal implant surgery (i.e. elevation of white blood count (WBC) or marked left shift in the WBC differential count).
— Grossly distorted anatomy due to congenital abnormalities.
— Rapid joint disease, bone absorption, osteopenia, poor bone quality, and/or osteoporosis.
— Inadequate tissue coverage over surgical site.
— Case not needing autogenous/allogenic bone graft, fusion, or fracture healing.
— Prior fusion at the level(s) to be treated.
— A patient unwilling or unable to comply with postoperative instructions.
— Any instance in which the implant would interfere with anatomical structures or expected physiological performances.

WARNINGS:
In any surgical procedure, the potential for complications exists. The risks and complications with these implants include but are not limited to:
— Infection or painful, swollen or inflamed implant site
— Fracture of the implant
— Loosening, bending, breaking or dislocation of the implant requiring revision surgery
— Bone resorption
— Bone over-production
— Allergic reaction(s) to implant material(s)
— Histological responses possibly involving macrophages and/or fibroblasts
— Migration of particle wear debris possibly resulting in a bodily response
— Embolism
— Subsidence of the device into the vertebral body.
— Bone loss and/or decrease in density due to stress shielding.
— Malalignment of anatomical structures (i.e. loss of normal spinal contours or change in height).
— Physiological reaction to implant devices due to foreign body intolerance including inflammation, local tissue reaction, and possible tumor formation.
— Loss of neurological function by several mechanisms, including direct compression by component parts, stretching of the spinal cord by component parts, vascular spinal cord compromise, or other mechanisms.

Return to top


ALLY™ Bone Screw

From: LBL-PMT-036 ALLY Bone Screw (PD-32-301) IFU, Rev 7

DESCRIPTION:
The ALLY™ Bone Screw is a partially or fully threaded cortical screw offered in various diameters and lengths. All screws are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single use only.

INDICATIONS FOR USE:
The ALLY™ Bone Screw is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

CONTRAINDICATIONS:
The ALLY™ Bone Screw should not be used in any of the following instances:
— Patients with active or suspected infection
— Physiologically or psychologically inadequate patient
— Inadequate skin, bone or neurovascular status
— Irreparable tendon system
— Possibility of conservative treatment
— Growing patients with open epiphyses

WARNINGS:
In any surgical procedure, the potential for complications exists. The risks and complications with the ALLY™ Bone Screw include but are not limited to:
— Infection or painful, swollen or inflamed implant site.
— Fracture of the implant.
— Allergic reaction(s) to implant material(s).
— Bone resorption.
— Bone over-production.
— Loosening or dislocation of the implant requiring revision surgery.
— Histological responses possibly involving macrophages and/or fibroblasts.
— Migration of particle wear debris possibly resulting in a bodily response.
— Embolism.


ALLY™ Bone Screw-L

From: LBL-PMT-140 ALLY Bone Screw-L IFU (PD-32-60X), Rev 3

DESCRIPTION:
The ALLY™ Bone Screw-L is a fully threaded cortical screw offered in two lengths. All screws are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). The implants are single-use only.

INDICATIONS FOR USE:
The ALLY™ Bone Screw-L is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

CONTRAINDICATIONS:
The ALLY™ Bone Screw-L should not be used in any of the following instances:
— Patients with active or suspected infection
— Physiologically or psychologically inadequate patient
— Inadequate skin, bone or neurovascular status
— Irreparable tendon system
— Possibility of conservative treatment
— Growing patients with open epiphyses

WARNINGS:
In any surgical procedure, the potential for complications exists. The risks and complications with the ALLY™ Bone Screw-L include but are not limited to:
— Infection or painful, swollen or inflamed implant site.
— Fracture of the implant.
— Allergic reaction(s) to implant material(s).
— Bone resorption.
— Bone over-production.
— Loosening or dislocation of the implant requiring revision surgery.
— Histological responses possibly involving macrophages and/or fibroblasts.
— Migration of particle wear debris possibly resulting in a bodily response.
— Embolism.

Return to top