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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.
Camber Spine
TLS 5.0 Interbody Cage, K121254*
• FDA 510(k) summary not available at press time
• Company affiliated with Andrew Freese, M.D.
Eleven Blade Solutions
Q-Fix Suture Anchor, Access tools, K122336*
• FDA 510(k) summary not available at press time
• In 1/13, ArthroCare entered into an agreement to purchase Eleven Blade Solutions, contingent upon Eleven Blade obtaining FDA clearance for certain suture-based anchor products
K7
K7C Spacer, K123388*
• Intervertebral fusion device with bone graft
• FDA 510(k) summary not available at press time
• Manufactured from Evonik’s VESTAKEEP PEEK polyetheretherketone (1st 510(k) clearance of a VESTAKEEP PEEK-based spinal fusion device)
LSK BioPartners
Mega 5.5 Spine System, K123476*
• Orthosis, spondylolisthesis spinal fixation
• FDA 510(k) summary not available at press time
Metric Medical Devices
Super Staple Classic, K123363*
• FDA 510(k) summary not available at press time
• In 1Q12, raised $0.66MM of a planned $1.8MM round of equity funding
Stanmore Implants
Sculptor Robotic Guidance Arm (Sculptor RGA), K121765
• For precision implant placement in unicompartmental knee surgery
• FDA 510(k) summary not available at press time
• Will commence limited U.S. launch for the UKS application in mid-2013
Sources: FDA 510(k) Releasable Database, 1/13; news releases; company web sites
