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

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