GMReis Gains FDA 510(k) Clearance for Quick – Radius Disposable Set

Orthopedic device company GMReis announced FDA 510(k) clearance to market the Quick – Radius Disposable Set, a single-use implant and instrument set featuring the VersaLock Volar Protect FLP Plate, a locking anatomical plate for fixation of fractures of the distal radius that has been developed to prevent irritation of the tendon of the flexor pollicis longus.

The FLP plate design includes a central recess to minimize flexor pollicis longus tendon contact injury, even with the more distal positioning of the plate.

The plate is compatible with the company’s Versa cortical and variable angle locking screws (+/-15°) Versalock Ø2.4 and 2.7 mm.

The disposable set is designed to help decrease sterilization cost and processing time, reduce suppliers’ stock cost and delays due to set unavailability and increase efficiency in the O.R.

Source: GMReis