Profemur E Cementless Hip Stem

• 3 recalls, same reason

  • Terminated Z-0183-2013 FDA Class II ·initiated 5 Sep 2012 ·via K111698, on the same 510(k)
  • Terminated Z-0185-2013 FDA Class II ·initiated 5 Sep 2012 ·via K111698, on the same 510(k)
  • Terminated Z-0184-2013 FDA Class II ·initiated 5 Sep 2012 ·via K111698, 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.

Full name

Profemur(R) E Cementless Hip Stem

510(k) Number

K111698 ↗

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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• What types of hip replacement surgeries is the Profemur E Cementless Hip Stem designed for, and how does it differ from cemented alternatives?

  The Profemur E Cementless Hip Stem is specifically designed for uncemented hip replacement surgeries, meaning it does not require bone cement for fixation. Instead, it relies on a press-fit mechanism and biological bonding to integrate with the femoral canal over time, promoting long-term stability. This contrasts with cemented alternatives, which use adhesive bone cement to secure the prosthesis in place. The semi-constrained design also allows for controlled movement while maintaining stability, making it suitable for patients requiring a balance of fixation and mobility.

• How many sizes or variants of the Profemur E Cementless Hip Stem are available, and how are they identified?

  The Profemur E Cementless Hip Stem comes in multiple sizes and variants, each identified by unique FEI numbers (e.g., 3020282716, 3007923096, etc.). These numbers correspond to specific dimensions and designs tailored to different patient anatomies, ensuring a precise fit during surgery. The exact list of FEI numbers is provided in the regulatory documentation, allowing surgeons to select the appropriate size for their patients.

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

  The Profemur E Cementless Hip Stem is intended for single-use only and is supplied sterile to meet surgical standards. Reuse is not recommended due to the risk of contamination and potential compromise of sterility, which could adversely affect patient outcomes. Proper sterile handling and disposal protocols must be followed as outlined in the device’s instructions for use.

• What storage requirements apply to the Profemur E Cementless Hip Stem before surgical use?

  Since the device is supplied sterile, it must be stored in accordance with sterile surgical protocols to maintain its integrity. This typically includes keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The manufacturer’s instructions for storage should be consulted for specific details, but general orthopedic surgical practices for sterile implants apply.

• What regulatory pathway was followed for the FDA clearance of the Profemur E Cementless Hip Stem, and what does this mean for its use?

  The Profemur E Cementless Hip Stem received Special 510(k) clearance from the FDA, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms that the device meets FDA safety and effectiveness requirements for its intended use in uncemented hip replacement surgeries. The classification as a Class III device reflects its higher-risk nature, but the clearance ensures it adheres to stringent regulatory standards before distribution.