DePuy rolls out 3D software-enabled bone device

DePuy Synthes Products
DePuy Synthes secured FDA clearance for the Maxframe device last year.

DePuy Synthes is introducing a device for the gradual correction of bone or soft tissue deformities. The device’s standout feature is its accompanying 3D planning software designed to cut treatment times and lower costs.

Other companies’ external circular fixation systems incorporate computer-aided components. But DePuy thinks it has differentiated its product through the use of algorithms, which it claims cut the need for manual measurements and number of inputs. If the device works as advertised, it could cut the number of x-rays patients with fractures, segmental defects and other conditions undergo.

DePuy has persuaded at least one surgeon of the strengths of its device.

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“The software eliminates significant sources of error inherent in earlier methods by removing the need to determine reference ring mounting parameters, as well as the requirement of ring orthogonality,” J. Spence Reid, M.D., an orthopedic surgeon, said in a statement. “The system also allows maximum flexibility in the location of strut attachment points on the ring which makes frame application easier, particularly in complex cases.”

DePuy cites multiple studies to argue for the value these improvements could deliver to healthcare systems. These include a paper that questions why use of Smith & Nephew’s Taylor Spatial Frame (TSF) and its six-axis deformity analysis computer program has in the past failed to eliminate the risk of residual deformity. The paper proposes using CT scans to determine mounting parameters and, in doing so, improve outcomes. 

Johnson & Johnson-subsidiary DePuy thinks its Maxframe Multi-Axial Correction System may cut the need for such workarounds. Getting customers to buy into that idea could deliver a boost to the business. 

Sales at J&J’s orthopedics unit underperformed the broader medical device business over the first six months of the year, with worldwide sales slipping 0.6% against overall growth of 4.0%.

DePuy secured 510(k) clearance (PDF) for the product from the FDA late last year through a filing that cited its Distraction Osteogenesis System and Smith & Nephew’s TSF as predicate devices. The submission cited software verification performed by DePuy in accordance with FDA and ISO processes in support of its standout 3D planning feature.