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.

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
 

World's First Biodegradable Joint Implant

Finland's Tampere University of Technology (TUT) reports that it has developed a biodegradable joint implant, which it believes to be a world first. Used to treat osteoarthritis and rheumatoid arthritis, the RegJoint recently received the CE mark.

The joint implant was developed in the mid-1990s in a collaborative effort involving TUT's Department of Biomedical Engineering, Conmed Linvatec Biomaterials, Scaffdex Ltd and a group of orthopaedic surgeons, among others, from Tampere University Hospital. Scaffdex will bring RegJoint to market.