Cleared Special

K031685 - TAG ROD BIORAPTOR SUTURE ANCHOR 7209317

K031685 is the FDA 510(k) clearance for TAG ROD BIORAPTOR SUTURE ANCHOR 7209317 by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code HWC) cleared through the Special 510(k) pathway after a 29-day FDA review.

K031685 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Jul 2003
Decision
29d
Days
Class 2
Risk

K031685 is an FDA 510(k) clearance for the TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Mansfield, US). The FDA issued a Cleared decision on July 1, 2003 after a review of 29 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.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K031685 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date July 01, 2003
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 564
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K031685.
ALANTECH GRAFT FIXATION SCREW
K031937 · Arthrocare Corp. · Sep 2003
LORENZ 2.4 SELF DRILLING SCREWS
K032228 · Walter Lorenz Surgical, Inc. · Aug 2003
BIORCI SCREW
K032224 · Smith & Nephew, Inc. · Aug 2003
RAPIDFIRE SELF DRILLING SCREWS
K031751 · Walter Lorenz Surgical, Inc. · Jun 2003
PERFORATED BIOABSORBABLE INTERFERENCE SCREW MEGAFIX
K030848 · Karl Storz Endoscopy · Jun 2003
LEFORTE SYSTEM BONE SCREW
K023365 · Jeil Medical Corporation · Apr 2003