Indications For Use - Spinal Kinetics M6-L Mode D'emploi

EN
The Spinal Kinetics M6®-L Artificial Lumbar Disc is intended to be used with the Spinal Kinetics M6-L
Artificial Lumbar Disc Instruments. Refer to the Spinal Kinetics M6-L Artificial Lumbar Disc Surgical
Technique Manual for implantation instructions.
Description
The Spinal Kinetics M6-L Artificial Lumbar Disc is an intervertebral disc prosthesis designed to
maintain motion of a functional spinal unit in the lumbar spine when the native disc is diseased.
The M6-L Artificial Disc is designed to maintain the natural behavior of a functional spinal unit by
replicating the biomechanical characteristics of the native disc. The core of the disc is composed of
a polycarbonate urethane polymer material. It is surrounded by a polyethylene fiber construct. The
device is comprised of an assembly of ultra high molecular weight polyethylene (UHMWPE) fibers
wound in multiple redundant layers around a polycarbonate urethane polymer (PCU) core and through
titanium alloy endplates. Biomechanical studies demonstrate that this unique design provides a
progressive resistance to motion, leading to physiologic motion in flexion, extension, lateral bending
and axial rotation as well as in compression and shear. The prosthetic disc also has a PCU sheath
surrounding the core and fiber construct designed to minimize any tissue ingrowth as well as the
migration of wear debris. Serrated keels located on the exterior surfaces of the device provide acute
fixation to the superior and inferior vertebral bodies. Both the endplates and keels are coated with
porous titanium to increase bone contact surface area and promote osseointegration.
keel
endplate
endplate
polymer sheath

Indications for Use

The Spinal Kinetics M6-L Artificial Lumbar Disc System is intended for use in skeletally mature
patients undergoing primary surgery for treatment of symptomatic degenerative disc disease (DDD)
of the lumbar spine at any one level between L3 through S1, who have not responded to at least 6
months of non-operative, conservative management. The DDD patient may also have up to 3mm of
spondylolisthesis at the involved level. The disease state is demonstrated by signs and/or symptoms
of disc herniation, osteophyte formation, or loss of disc height.
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