Cleared Special

K032224 - BIORCI SCREW

K032224 is an FDA 510(k) clearance for BIORCI SCREW, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code HWC cleared through the Special 510(k) pathway after a 18-day FDA review.

K032224 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
18d
Days
Class 2
Risk

K032224 is an FDA 510(k) clearance for the BIORCI SCREW. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Andover, US). The FDA issued a Cleared decision on August 8, 2003 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K032224

510(k) Number K032224 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2003
Decision Date August 08, 2003
Days to Decision 18 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 122d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

HWC Device Classification - Class 2, Special Controls

Product Code HWC Screw, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HWC Screw, Fixation, Bone

All 1069
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K032224.
OSTEOMED SUBTALAR IMPLANT SYSTEM
K031155 · Osteomed LP · Aug 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · Walter Lorenz Surgical, Inc. · Aug 2003
HBS HEADLESS BONE SCREW
K030302 · Schoening & Assoc., Inc. · Aug 2003
PCW PERCUTANEOUS COMPRESSION WIRE
K031050 · Millennium Medical Technologies, Inc. · Jul 2003
TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318
K031685 · Smith & Nephew, Inc. · Jul 2003
MINILOK QUICKANCHOR PLUS
K030995 · Mitek Worldwide · Jun 2003
K032224 · BIORCI SCREW
Download PDF FDA Summary Smith & Nephew, Inc.