7A ODEP Rating
Over eight years of clinical data from Europe and an IDE study in the United States and Canada.
In a two-year, multicentre IDE study of 116 patients, Nano Stemless Shoulder was proven to be an effective bone sparing option for Total Shoulder Arthroplasty demonstrating increased mobility and reduced pain for the patients compared to the preoperative state.
Mean ASES score for the Nano Stemless Shoulder was comparable to the Mini Stem
Excellent implant survivorship of 92.2% at two years
Nine subjects in the Nano group had complications (1 humeral fracture, 2 revisions, 1 glenoid perforation, 1 dislocation and 4 glenoid fractures)
100% of the patients completing two year visits successfully passed the radiographic success criteria with no progressive radiolucencies of the humeral component >2mm and no migration or subsidence of the humeral component
Mean VAS pain score reduced significantly post-surgery compared to pre-operatively
Statistically significant improvement in range of motion compared to pre-operatively
Significant improvement in Activities of Daily Living (ADL) compared to pre-operatively
Wing etch marks on proximal face to facilitate visualisation of the component in bone and aid in ease of revision if needed
25%–35% more surface area coated with PPS® Porous Plasma Spray compared to mini stem intended to aid in biological fixation
Female taper to allow for unobstructed view of the glenoid
PPS coating to facilitate biological fixation
Implant accepts Versa-Dial® Humeral Heads
Position of implant is independent of humeral canal, enabling optimal coverage and tensioning
Implant cannulated to allow for accurate insertion over Steinmann Pin
Offering unmatched humeral stem options, advanced glenoid fixation and streamlined instrumentation, the Comprehensive Shoulder System consists of an elaborate stem platform that includes a stemless, micro, mini, standard, revision and fracture stem – all as part of an interchangeable and truly convertible system that works together to achieve the ideal solution for each individual surgeon and patient.
Instrumentation for the Comprehensive Nano Stemless Shoulder was designed to complement the surgical work flow, facilitating ease of use in the OR.
