Bodycad Receives FDA 510(k) Clearance for Personalized Unicompartmental Knee

By Julie A. Vetalice

Bodycad received FDA 510(k) clearance to market the Bodycad Unicompartmental Knee joint reconstruction implant system.

Bodycad's process is based on proprietary 3D rendering of medical images of the patient's anatomy. Their approach to joint reconstruction, described as a personalized restoration, is delivered as a "procedure in a box" with the patient-specific implant and instruments.

In 2Q16, the company introduced Bodycad OnCall™, personalized, individually-manufactured orthopaedic restorations for complex cases such as oncology, revision and osteotomy.

Sources: Bodycad; ORTHOWORLD Inc.


Product Labels: Knee Replacement

Tags: 510(k) Clearance, Regulatory