Strategic Orthopaedic-related 510(k) Update

• Posted in Legal, Clinical & Regulatory | March 12, 2012 | Comments (0)
• By: BONEZONE

Tags: fda, 510(k), FDA clearance

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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.

Arrowhead Medical Device Technologies
Arrow-Lok Digital Fusion System, K112675*

• Stainless steel, 3-dimensional arrow shape for fixation of osteotomies, arthrodeses and reconstruction in lesser toes

Biomet
Comprehensive Reverse Shoulder - El Humeral Bearings, K113121
Comprehensive Reverse Shoulder Humeral Tray, K113069

• Indicated for-primary, fracture or revision total shoulder replacement; modifications to original K080642

BioStructures
Interface Bone Void Filler, K112857

• For use in the posterolateral spine when mixed with autograft
• Builds upon a previous clearance for use in the extremities and pelvis

DNE
R&R External Fixation System, K113106*

• Aluminum, Ti6A14V alloy, stainless steel
• For open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities and correction of segmental or nonsegmental bony or soft tissue defects

Double Engine Medical Material
Locking Plate and Screw, K112819*

• Company has products for trauma and spine

Eden Spine
Giza Thoracolumbar Vertebral Body Replacement, K112429

• Titanium alloy
• Expandable vertebral body replacement device featuring rotatable endplates to provide multiple angulation options