Kicking off 2020, two of Memphis’ stable of medical device companies received coveted 510(k) premarket clearances from the FDA.
In2Bones Global Inc. received two U.S. Food and Drug Administration (FDA) clearances: for its Avenger system related to elbows on Jan. 7 and for its Quantum total ankle replacement system on Jan. 29.
And CrossRoads Extremity Systems received its own FDA clearance, on Jan. 10, allowing it to launch its HiMax Plus system for foot fusions.
Attaining the FDA’s 510(k) clearance allows for companies to market their product in the U.S.
In2Bones
Founded in 2015, In2Bones designs and manufactures devices for disorders and injuries of the upper extremities (hand, wrist, and elbow) as well as the lower extremities (foot and ankle).
The Avenger radial head system is a prosthesis that restores elbow joint function. In2Bones said its implant and accompanying sterile, single-use instruments can have as much as $400 in cost savings per surgery.
The Quantum system is In2Bones’ entry into the total ankle replacement market. The product is marketed toward patients with arthritis. The system is designed to work with OrthoPlanify patient specific instrumentation, which uses CT guided technology.
The Quantum total ankle product line is expected to fully launch in the first quarter of 2021.
In 2019, In2Bones had 14 local employees and 45 total employees, according to Memphis Business Journal research.
CrossRoads
CrossRoads focuses on fixation in the foot and ankle medical device market through its Active Stabilization technology.
The latest clearance for CrossRoads, which holds more than a dozen patents and multiple FDA clearances, is its HiMax Plus wide-body fixation system. HiMax Plus is a foot bone fusion system that provides “flush insertion, market leading compression, and a wide bridge for enhanced stability.”
Last spring, CrossRoads received a capital infusion from New York-based private equity firm HealthpointCapital. And in November, multiple technology assets were acquired from Utah-based Surgical Frontiers LLC to be paired with CrossRoads.
Founded in 2014, Crossroads has more than 30 employees, with the bulk of those working in Memphis.
