Exactech shared updates regarding ExactechGPS® computer-assisted surgical technology, with successful first total shoulder procedures announced in September 2016 and the first U.S. knee revision procedure following in October.
The total shoulder application is being piloted in Europe, where specialists performed both an anatomic and a reverse total shoulder replacement using Equinoxe® implants and instruments. In the U.S., the shoulder application is undergoing FDA premarket review.
The revision knee application received FDA 510(k) clearance in July 2016 under Blue Ortho, and is reported to have secured EU approval as well.
GPS has been a part of EXAC’s portfolio for years. The system, which combines pre-op planning with intra-op real time computer-assistance, was co-developed with Blue Ortho, EXAC’s partner since 2009. Its first application in total knee arthroplasty was cleared in 4Q10 and launched in late 1Q14. A second version followed in 1Q15, featuring a larger and more convenient user interface. Leadership has suggested potential for use in hip and other applications, in the future.
A variety of planning, computer-assisted and navigation systems are available today for use throughout various market segments. Highlights from hip and knee technologies in 2016 alone include:
Corin received FDA 510(k) clearance to market the Optimized Positioning System (OPS™), reportedly the first FDA-cleared technology to support functional, patient-specific component alignment in total hip replacement.
In 1Q16, OrthAlign received FDA 510(k) clearance to market UniAlign™, a handheld, single-use navigation device for Unicompartmental Knee Arthroplasty. OrthAlign also entered into a multi-country distribution agreement with Smith & Nephew for KneeAlign® Total Knee Arthroplasty component alignment technology, and launched the OrthAlign Plus® for Total Hip Arthroplasty device.
OrthoGrid introduced new HipGrid® Drone™ accessories to address C-arm distortion and magnification issues during surgical planning for total hip arthroplasty.
Having acquired Blue Belt Technologies in 1Q16, Smith & Nephew announced in 3Q16 the first surgical case using the NAVIO™ robotics-assisted surgical system in total knee replacement, using the JOURNEY™ II BCS knee.
Still more background can be found in the May 2016 article, “Computer-Assisted Technologies Gain Traction in Orthopaedics.”