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Safety

As with all medical devices, there are risks and considerations to device use. Please refer to the device labeling for a full discussion of potential risks, contraindications, warnings, precautions, and instructions for use. Rx only.

CORUS™ Spinal System–X

From: LBL-PMT-212 Rev 3 - IFU, Spinal System-X (DX-22-300) with PD-04-470, US

Device Description
The CORUS Spinal System-X disposable instruments are used to access and prepare the posterior cervical or lumbar 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:
FOR CERVICAL FUSION:
The CORUS™ Spinal System-X is a set of instruments indicated to be used to perform posterior cervical fusion in patients with cervical degenerative disc disease.

FOR LUMBAR FUSION:
The CORUS™ Spinal System-X is a set of instruments indicated to be used to perform posterior lumbar fusion in patients with lumbar degenerative disc disease.

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

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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.

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CAVUX® FFS

From: LBL-PMT-228 Rev 0

Device Description
CAVUX Cages are used in conjunction with ALLY Bone Screws as an integrated construct referred to as the CAVUX Facet Fixation System “CAVUX FFS.” The device achieves facet fixation by spanning the interspace with points of fixation at each end of the construct. The device provides rigid fixation as an adjunct to fusion with the bone screw providing additional anchoring into the lateral mass. The titanium constructs are offered in various footprints and heights, and are manufactured from implant grade titanium alloy (6Al-4V ELI Titanium). CAVUX FFS is single-use only, provided sterile (gamma sterilized) with pre-attached, disposable, delivery handles.
CAVUX FFS should be implanted only using the CORUS™ Spinal System.

INDICATIONS FOR USE:
CAVUX® Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX FFS is placed bilaterally through a posterior surgical approach and spans the interspace with points of fixation at each end of the construct. CAVUX FFS is intended for temporary stabilization as an adjunct to posterior cervical fusion in skeletally mature patients. CAVUX FFS is indicated for patients requiring a revision for an anterior pseudarthrosis at one level, from C3 to C7, with autogenous and/or allogenic bone graft.

CONTRAINDICATIONS:
Contraindications may be relative or absolute and must be carefully weighed against the patient’s entire evaluation. The following conditions are contraindicated:
— Active systemic infection or infection at operative site.
— Allergy to titanium or instrument materials
— Foreign body sensitivity
— Cancer of the spine
— Pregnancy
— Paget’s disease, rheumatoid arthritis
— Rapid joint disease, bone absorption, poor bone quality, osteoporosis or osteopenia, neurotrophic diseases
— Incompatible anatomy (e.g. due to congenital abnormalities)
— Skeletally immature
— Any condition that would preclude the potential benefit of spinal implant surgery
— Mental illness, alcoholism, or drug abuse
— Use of nonsteroidal anti-inflammatory agents or anticoagulants
— Are uncooperative, unwilling or unable (e.g. neurologic disorders) to comply with postoperative instructions

WARNINGS:
In any surgical procedure, there is a risk of potential complications, including, but not limited to:
— Infection, pain, swelling or inflammation at treatment site
— Device loosening, malposition, expulsion, bending, breakage, dislocation, subsidence or migration, including particle wear debris
— Sensitivity due to fretting-corrosion or prominence of the device
— Revision surgery
— Bone resorption or over-production
— Allergic reaction(s) to device or surgical instruments
— Embolism
— Malalignment of anatomical structures (e.g.. loss of normal spinal contours)
— Physiological reaction due to foreign body intolerance including inflammation, local tissue reaction, and possible tumor formation
— Loss of neurological function, including direct compression by component parts, stretching of the spinal cord by component parts, vascular spinal cord compromise or other mechanisms

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

From: LBL-PMT-045 Rev 10 - CAVUX Cervical Cage-B, -SB, -X (PD-31-20X) IFU

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.

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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.

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