Strategic Orthopaedic-related 510(k) Update

The following companies recently received strategic FDA 510(k) clearances in the orthopaedic space. For certain companies, this represents a first clearance of an orthopaedic-related product. These are denoted with an asterisk.

Pantheon Spinal
Spinal Interbody Fusion Device, K113781*

  • Summary not available at press time
  • Company formed 2011 by a spine surgeon
  • Portfolio includes Epiphany for use in L5-S1 region, Pontus secondary implant to bridge remaining portion of lumbar spine

Pinnacle Spine
InFill Oblique TLIF Device, K124012

  • Radiolucent PEEK and tantalum intervertebral body fusion device for use with autogenous bone graft and supplemental fixation in lumbar spine Providence Medical Technology PMT Cervical Cage, K122801
  • Titanium-based intervertebral fusion device for use with autogenous bone graft and supplemental fixation in the cervical spine

Spine Wave
Staxx Interbody System, K123461

  • Intervertebral body fusion device comprising wafers stacked into an expandable implant
  • To be used with autogenous bone graft
  • Components manufactured from PEEK-OPTIMA and PEEK-OPTIMA with 6% Barium Sulfate

Synergy Biomedical
Biosphere Bioactive Bone Graft Putty, K122868*

  • Osteoconductive, bioactive bone void filler composed of bioactive glass particles

X-Spine Systems
Zygafix Spinal Facet Screw System, K123932

  • Titanium-based system for use in lumbar spine in bilateral, transfacet fixation of the facet joint, for use with autogenous bone graft
  • Not for use with bone cement

Sources: FDA 510(k) Releasable Database, news releases, company web sites