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Back Updated on: Nov. 13th, 2013

PrimaLOK™SP by OsteoMed

PrimaLOKâ¢SP
  

Product Description

Next-generation polyaxial technology for optimal placement and enhanced fixation to accommodate anatomic variations with minimal tissue disruption.

Why use the PrimaLOK™SP?

  • Polyaxial grips optimize implant fixation to the spinous processes — ideal for L5-S1 placement
  • Seven sizes from 4mm-18mm accommodate variations in patient anatomy
  • Large bone graft window with floor enhances stability and graft containment
  • Easy-to-use instrument options for a variety of minimally disruptive surgical approaches
  • Sterile packaging maintains implant quality and O.R. speed
DESCRIPTION AND PATIENT INDICATIONS
The OsteoMed Spine PrimaLOK™ SP Interspinous Fusion System is intended toprovide immobilization and stabilization of spinal segments as an adjunct to fusionof the thoracic, lumbar and/or sacral spine. PrimaLOK SP is a bilateral locking platesystem which attaches to the posterior non-cervical spine at the spinous processes.It is available in various heights and widths to accommodate differing anatomic requirements.
Surgical procedures appropriate for use with PrimaLOK SP include, but are notlimited to:
  • Supplemental fixation for Anterior Lumbar Interbody Fusion (ALIF), Transforaminal Lumbar Interbody Fusion (TLIF), Lateral Lumbar Interbody Fusion (LLIF), Posterior Lumbar Interbody Fusion (PLIF), Posterior Lateral Fusion (PLF) and lumbar facet screw procedures.
  • Supplemental fixation for failed fusion revision and hybrid constructs
INDICATIONS FOR USE
The PrimaLOK SP Interspinous Fusion System is a posterior, non-pediclesupplemental fixation device, intended for use in the non-cervical spine (T1-S1). Itis intended for plate fixation/attachment to the spinous process for the purpose ofachieving supplemental fusion in the following conditions: degenerative disc disease(defined as back pain of discogenic origin with degeneration of the disc confirmedby history and radiographic studies), spondylolisthesis, trauma (i.e., fracture ordislocation), and/or tumor. The PrimaLOK SP Interspinous Fusion System is intendedfor use at one level, with bone graft material, and not intended for stand-alone use.
DESIGN RATIONALE
Rethinking lumbar fixation in a fresh new way inspired the design of the OsteoMedSpine PrimaLOK™ SP Interspinous Fusion System. PrimaLOK SP is a next generationposterior lumbar spinous process fixation device. Patent-pending polyaxial technologyprovides for optimal placement and enhanced fixation to accommodate anatomicvariations with minimal disruption to anatomy. These unique features, combinedwith easy-to-use instrument options for a variety of surgical approaches, result in astreamlined fixation solution tailored to the needs of surgeons and patients.

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