Cleared Special

K031162 - SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM

K031162 is an FDA 510(k) clearance for SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Special 510(k) pathway after a 17-day FDA review.

K031162 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
17d
Days
Class 2
Risk

K031162 is an FDA 510(k) clearance for the SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on May 1, 2003 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - 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 - K031162

510(k) Number K031162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2003
Decision Date May 01, 2003
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 - JDQ Cerclage, Fixation

All 130
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K031162.
OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS
K040199 · Osseus, LLC · Feb 2004
ISO-ELASTIC CERCLAGE SYSTEM
K030256 · Kinamed, Inc. · Oct 2003
SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM
K031508 · Synthes (Usa) · May 2003
OSSE-LIGN
K023564 · Osseus, LLC · Mar 2003
SYNTHES STERNAL FIXATION SYSTEM
K010943 · Synthes (Usa) · Jun 2001
PECTOFIX STERNAL REPAIR WIRE
K003951 · Pectofix, Inc. · Mar 2001
K031162 · SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM
Download PDF FDA Summary Smith & Nephew, Inc.