Profemur Xtr Hip Stem

• 3 recalls, same reason

  • Terminated Z-0183-2013 FDA Class II ·initiated 5 Sep 2012 ·via K052915, on the same 510(k)
  • Terminated Z-0185-2013 FDA Class II ·initiated 5 Sep 2012 ·via K052915, on the same 510(k)
  • Terminated Z-0184-2013 FDA Class II ·initiated 5 Sep 2012 ·via K052915, on the same 510(k)

  There may be inaccuracies on the labeled shelf life on all products packaged at the Toulon, France facility.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K052915 ↗

FDA Product Code

KWA

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Profemur Z Classic Stems

  Class II

  FDA 510(k) K123434 Active Cleared 5 Feb 2013

• Cannulated Screw System

  Class II

  FDA 510(k) K143460 Active Cleared 23 Jan 2015

• Small Bone Wedge

  Class II

  FDA 510(k) K070592 Active Cleared 5 Oct 2007

• BIOFOAM Bone Wedge

  Class II

  FDA 510(k) K142724 Active Cleared 20 May 2015

• PROPHECY INVISION Preoperative Navigation Alignment System

  Class II

  FDA 510(k) K162795 Active Cleared 22 Feb 2017

• Salvation Beams and Bolts System

  Class II

  FDA 510(k) K140741 Active Cleared 15 May 2014

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• Is the Profemur Xtr Hip Stem designed for use in revision surgeries, or is it only intended for primary hip arthroplasty?

  The Profemur Xtr Hip Stem is explicitly designed for primary hip arthroplasty only, as stated in its description. It is not indicated for revision surgeries, which involve replacing previously implanted hip components. Always verify surgical indications with the manufacturer’s instructions for use before proceeding.

• How many different sizes or variants of the Profemur Xtr Hip Stem are available, and how can I identify them?

  The device comes in multiple sizes and variants, each associated with a unique registration number (e.g., 8043792, 3020282716, etc.). These numbers are listed in the regulatory data and correspond to specific stem designs or dimensions. For precise sizing, refer to the manufacturer’s packaging or catalog, as the exact measurements are not detailed in the provided data.

• Is the Profemur Xtr Hip Stem reusable, or is it intended for single-use only?

  The device is intended for single-use only, as explicitly stated in the description. It is supplied sterile and should not be reused after implantation to maintain safety and sterility standards.

• What type of regulatory clearance does the Profemur Xtr Hip Stem hold, and how does that affect its use?

  The Profemur Xtr Hip Stem holds FDA 510(k) clearance (K052915) under regulation number 888.3330, classifying it as a Class III medical device. This clearance confirms it meets FDA standards for safety and effectiveness as a semi-constrained, metal, uncemented femoral prosthesis. However, compliance with the manufacturer’s instructions for use remains critical for proper surgical application.

• How should the Profemur Xtr Hip Stem be stored before use, and are there any special handling requirements?

  While the data does not specify storage conditions, the device is supplied sterile, so it should be stored in its original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s storage guidelines (available in the IFU) to preserve sterility and functionality until use.