Additive Orthopaedics said yesterday that it won FDA 510(k) clearance for its patient specific 3D-printed locking lattice plates.
The newly cleared devices from the Little Silver, N.J.-based company now have indications from the federal watchdog for the alignment, stabilization and fusion of fractures, osteotomies and arthrodesis of small bones such as those in the foot and ankle.
“There will always be a need for traditional off-the-shelf orthopedic devices, but in cases of implant revisions, limb salvage, and trauma, using printing to manufacture a patient specific device can potentially lead to a better outcome. Although we are still in the early stages for 3D printed patient specific implants, it has been a terrific journey developing the market in foot and ankle orthopaedics,” prez Greg Kowalczyk said in a press release.
Additive Ortho said that its patient specific implants will be the cornerstone of its Game Plan integrated surgical planning system which it hopes to launch later this year.
Last May, Additive Orthopaedics said that it won FDA 510(k) clearance for its Patient Specific 3D-printed bone segments.