Zimmer scores 510(k) nod for device to aid surgeons with reverse arthroplasty procedures
Zimmer Holdings, Inc. (ZMH) may have gone down swinging in its most recent courtroom drama with Stryker, but the orthopedics giant may be set to prop itself back up.
The FDA gave the Warsaw, Ind.-based company 510(k) clearance for the Patient Specific Instrument Shoulder system. The clearance is to work hand-in-hand with another Zimmer device–the Trabecular Metal Reverse Shoulder system–for reverse arthroplasty procedures. The PSI Shoulder system, which has had limited availability in Europe since May, uses 3-D visualization software lets surgeons create customized plans for each patient, then gives patient-specific surgical instrument guides to help the surgeon place the implant in the correct placement.
According to the press release, the device ”enables the surgeon to plan the implant size and position, as well as the bone preparation, even the positioning of the screws.”