This month’s recap highlights 510(k)s and a CE Mark announcement made from the AAOS exhibit hall floor. A few products gained clearance earlier this year and the company strategically held its announcement for this month.
Exactech Alteon Acetabular Cup and XLE Liner
OrthoGrid Systems PhantomMSK
Joint Replacement: Hip
Exactech received K182802, clearance to market the Alteon® Acetabular Cup and XLE® Liner for hip reconstruction. This device was submitted in September 2018 and cleared in March 2019. The cup provides multiple implant configurations and bearing options for the Alteon portfolio, and features TAC™ asymmetric porous coating. Alteon XLE highly crosslinked vitamin-E enhanced acetabular liners undergo a patented gamma irradiation and mechanical annealing process to achieve the desired crosslink density.
In 2H19, Exactech will aggressively expand its rollout of the Alteon Cup to serve more surgeons throughout the U.S. Full launch is expected later this year.
OrthoGrid Systems received K182332, FDA 510(k) clearance to market the PhantomMSK™ intraoperative image-processing software. This system was submitted in August 2018 and cleared in February 2019, and represents OrthoGrid’s first FDA-cleared product.
PhantomMSK provides correction for fluoroscopic distortion in multiple procedures, including direct anterior approach total hip arthroplasty, where it is designed to help restore native hip biomechanics with alignment considerations for leg length, femoral offset, cup inclination, femoral abduction, pelvic tilt, and pelvic obliquity. It is not for primary image interpretation.
PhantomMSK does not include any custom computer hardware and is a software-based device that can be run on a “commercial off-the-shelf” system (such as PC, keyboard, mouse, touchscreen monitor, etc.) that meet minimum performance requirements. Furthermore, PhantomMSK operates on image principles that are not vendor specific. To operate PhantomMSK, a fluoroscopic image is acquired from a C-arm and displayed outside the sterile field, where image analysis tools can be used at the surgeon’s discretion.
Maxx Orthopedics Freedom Total Knee System
Nvision Biomedical Vector
Joint Replacement, Knee
Maxx Orthopedics was granted K182574, FDA 510(k) clearance to market the Freedom® Ultra-Congruent liner for cemented use as part of the Freedom Total Knee® system. This device was submitted in September 2018 and cleared in January 2019.
The ultra-high molecular weight polyethylene liner is designed to achieve a higher level of constraint than is typically achieved with traditional cruciate-retaining knees. It features a deep anterior patellar cut-out to allow for tendon clearance, a prominent anterior lip to prevent anterior subluxation of the femur and a prominent posterior lip that resists posterior translation of the femur. Thicknesses vary in 1mm increments throughout the size range.
Trauma, Lower Extremities
Nvision Biomedical Technologies received K182949, FDA 510(k) clearance to market Vector™, the first foot/ankle implant made from PEEK-OPTIMA™ HA Enhanced polymer from Invibio Biomaterial Solutions. This device was submitted in November 2018 and cleared in February 2019.
The device is also reportedly the first lower extremity implant to use Structural Encoding® to enable Unique Device Identification. Structural Encoding, licensed from the Watershed Idea Foundry, is able to embed the entire history of the device; this data can be read by simple x-ray imaging.
This clearance represents Nvision’s entry to the extremities trauma market, expanding from its previous focus on spine. Vector enables a standard surgical technique that allows direct drilling and the exact placement of the implant, and is an alternative to the conventional K-wire implant procedure to treat hammertoe, claw toe and mallet toe.
Now, one last regulatory announcement from the floor, but not a 510(k):
AxioMed received approval under the CE Mark for its viscoelastic cervical disc device. Full ex-U.S. launch is slated to occur within 2019.
AxioMed’s device is reportedly the only viscoelastic disc to complete a U.S. Investigational Device lumbar clinical study, with over five years of clinical follow-up data. U.S. launch is expected in 2020.
Last month, parent company KICVentures announced that it seeks funding to prepare its spine portfolio companies, AxioMed and NanoFUSE Biologics, to be acquisition targets in the next three to five years. Assets include AxioMed Freedom cervical and lumbar disc replacements and NanoFUSE bioactive glass.
Sources: Company press releases, websites and the 510(k) Premarket Notification Database; images courtesy of manufacturers