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AAOS 2016 Recap: Product Launches and Clearances

Orthobiologics
Biologics continue to gain momentum in the industry, illustrated by the following launches.

AlloSource

  • Launched ProChondrix® Cartilage Restoration Matrix, a cellular 3D fresh cartilage allograft to support cartilage regeneration, and designed to match biomechanical and biochemical properties of normal hyaline cartilage and restore a smooth articular cartilage surface.

Bioventus

BONESUPPORT


Spine

Spine, the second largest segment in orthopaedics by revenue, saw nearly as many announcements as the market leader, joint reconstruction. Notably, Stryker Spine announced two product launches and a 510(k) clearance.

Cardinal Spine

EOS

  • Received CE Mark approval for spineEOS, an online 3D planning software based on EOS bi-planar imaging.
  • This supports the creation of an optimized treatment plan to achieve improved sagittal alignment in the treatment of Adolescent Idiopathic Scoliosis and adult degenerative/deformative spine conditions.

Stryker

  • Received FDA 510(k) clearance for Tritanium® PL, a highly-porous posterior lumbar cage manufactured via additive manufacturing. Launch will occur in 2Q16.
  • Launched the Xia 4.5 Cortical Trajectory implants and instruments for LITe® (Less Invasive Technologies) Lumbar Interbody Fusion procedures. The cortical trajectory procedure allows for a smaller midline incision, and is intended to be more muscle-sparing than standard open procedures.
  • Launched the Aero®-C Cervical Stability System, reportedly the only ACDF device to offer uniform compression across the interbody space. The Aero platform employs an advanced anchor fixation system designed to draw the vertebral bodies toward the implant, creating compressive forces at the implant-to-endplate interface and providing an environment for fusion.

ulrich

  • ulrich medical USA launched uNion®, a titanium alloy cervical plate for stabilization and anterior fixation as an adjunct to fusion in the treatment of degenerative disc disease.
  • uNion features a low-profile plate design with streamlined instrumentation, a large graft window and a range of implant sizes for 1- to 4-level treatment requirements.

Xtant Medical

  • Received CE Mark approval for the Aranax™ cervical plate and the Irix-A™ standalone anterior lumbar fusion device.
  • Aranax comprises a pre-sterilized, ready-to-use implant, while Irix-A consists of an integrated, PEEK-enclosed titanium ring. In the U.S., Aranax received FDA 510(k) clearance in 3Q15 and Irix-A launched in 1Q15.


Trauma

Foot and ankle remains an attractive market, including in trauma, evidenced by Extremity Medical’s product launches.

Extremity Medical

  • Commenced U.S. launch of IO FIX 2.0™ implants and instruments for midfoot fusion indications.
  • While based on the original IO FIX system, this next-generation line is modular, supporting greater intra-operative versatility. To date, >20,000 of its constructs have been implanted worldwide.

Tyber Medical


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