Profemur XM Wingless Distal Centralizer, Perfecta Distal Centralizer

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K113019 ↗

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 type of hip arthroplasty procedure is the Profemur XM Wingless Distal Centralizer designed for, and how does it differ from other acetabular components?

  The Profemur XM Wingless Distal Centralizer is specifically designed for cemented total hip arthroplasty as a semi-constrained metal uncemented acetabular component. Unlike winged centralizers, this device lacks wings, which may reduce soft-tissue irritation or impingement risks during femoral positioning. It is engineered to stabilize the femoral component in uncemented applications, ensuring improved alignment and fixation within the hip joint system.

• Is this device intended for single-use or can it be reused in multiple procedures?

  The Profemur XM Wingless Distal Centralizer is explicitly described as a reusable orthopedic implant. While not explicitly labeled as single-use, its classification as a reusable device aligns with standard orthopedic implant practices where sterility and handling protocols are critical for repeated use across procedures.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use in clinical settings?

  The device received FDA 510(k) clearance (K113019) under a Special 510(k) review with a decision of *Substantially Equivalent* (SESE) to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared product, ensuring compliance with Class III regulatory requirements for prostheses in the hip joint system (product code KWA). Clinically, this clearance indicates it meets FDA standards for safety and effectiveness in cemented total hip arthroplasty.

• Are there specific storage or handling instructions provided for this device beyond general orthopedic implant protocols?

  The provided data does not specify unique storage or handling instructions beyond standard orthopedic implant protocols. As a reusable metal implant, it should be stored in a clean, dry environment to prevent contamination or damage. Sterilization procedures (e.g., autoclave or ethylene oxide) would follow established orthopedic implant guidelines, though exact methods are not detailed in the data.