Zimmer scores 510(k) nod for device to aid surgeons with reverse arthroplasty procedures

2:47 pm by | 2 Comments

FDA logoZimmer 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.”

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Lindsey Alexander

By Lindsey Alexander

Lindsey Alexander is an Indiana-based freelance writer and editor covering the medical device industry. She earned a degree in journalism from Indiana University and a master's from Purdue.
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Did you perhaps mean aRthroplasty?  Or has a new word been coined?  

I appreciate MedCityNews, in fact have frequently linked to it or recommended it entire at LinkedIn.  I also appreciate the pressure online publishing time constraints place on journalists and authors.  However, the fine content is all too often hindered by jejeune editorial errors (or worse yet, amateur proofreading), detracting from your professional aspirations.  You can, and should, do better.

Veronica Combs
Veronica Combs moderator

@kfunk937 Thanks for the heads up. You are right on all counts (nothing drives home a point to an editor like the correct use of jejune ;-).