Rapidfire Self Drilling Screws

• • Terminated Z-0626-2021 FDA Class II ·initiated 25 Nov 2020

  Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

510(k) Number

K031751 ↗

FDA Product Code

HWC

Device Class

Class II

Regulation

21 CFR Part 888.3040

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Lorenz 1.0 Mm System

  Class II

  FDA 510(k) K922741 Active Cleared 23 Dec 1992

• Lorenz 1.5 X 4 Mm Lactosorb Tap Free Screw

  Class II

  FDA 510(k) K021522 Active Cleared 21 May 2002

• Lorenz External Mandibular Distractor

  Class II

  FDA 510(k) K992873 Active Cleared 17 Sep 1999

• Steinhauser Titanium Mini Bone Plates & Screws

  Class II

  FDA 510(k) K862482 Active Cleared 25 Jul 1986

• Lorenz Pectus Support Bar

  Class II

  FDA 510(k) K972420 Active Cleared 11 Aug 1997

• Lorenz Maxilla (Le Fort) Distraction System

  Class II

  FDA 510(k) K982604 Active Cleared 23 Oct 1998

See all devices from Walter Lorenz Surgical, Inc. →

• What are Rapidfire Self Drilling Screws used for?

  Rapidfire Self Drilling Screws are orthopedic fixation devices designed specifically for secure internal bone stabilization. Their self-drilling feature eliminates the need for separate drilling tools, streamlining insertion into both cortical and cancellous bone. This reduces operative time and minimizes tissue trauma, making them ideal for procedures requiring stable anchorage in orthopedic surgeries.

• Are these screws supplied sterile and for single-use?

  Yes, the Rapidfire Self Drilling Screws are supplied sterile and intended exclusively for single-use in orthopedic procedures. This ensures patient safety and compliance with medical device standards, preventing cross-contamination and maintaining sterility throughout the surgical process.

• How do the self-drilling screws differ from traditional screws?

  Unlike traditional screws that require a separate drilling step, Rapidfire Self Drilling Screws integrate the drilling mechanism into the screw itself. This design simplifies the surgical procedure by reducing the number of instruments needed, lowering operative time, and potentially decreasing tissue trauma during insertion into bone.

• What regulatory classification and approval do these screws hold?

  The Rapidfire Self Drilling Screws are classified under 21 CFR 888.3040 as Class II medical devices, categorized under product code HWC. They received FDA 510(k) clearance (K031751) with a special review classification, determined to be substantially equivalent (SESE) to a predicate device. This classification aligns with orthopedic surgical standards.

• Are there different sizes or models available for these screws?

  While the provided data does not specify exact sizes or models, Rapidfire Self Drilling Screws are designed to accommodate various orthopedic fixation needs. Their threaded design ensures adaptability for both cortical and cancellous bone, suggesting versatility in clinical applications. For precise sizing or model selection, consult the manufacturer’s technical documentation or product catalog.