Cleared Special

K072212 - JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K072212 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
211d
Days
Class 2
Risk

K072212 is an FDA 510(k) clearance for the JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 7, 2008 after a review of 211 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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. Standard predicate reliance. 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 K072212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2007
Decision Date March 07, 2008
Days to Decision 211 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 122d · This submission: 211d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 402
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K072212.
DYNEX® External Fixation Systems
K260900 · Vilex, LLC · Apr 2026
QuikFix External Fixator: Knee-Spanning Pack
K260112 · Stabiliz Orthopaedics, Inc. · Mar 2026
Excelsior System
K253291 · Blue Ocean Global · Jan 2026
Hoffmann LRF System
K253202 · Stryker GmbH · Dec 2025
Monkey Rings External Ring Fixation System
K253613 · Paragon 28, Inc. · Dec 2025
Medusa Orthopedics Boa External Fixation System
K252555 · Medusa Orthopedics, LLC · Nov 2025