Cleared Traditional

K020311 - CLEARVIEW WRIST FIXATOR

K020311 is an FDA 510(k) clearance for CLEARVIEW WRIST FIXATOR, manufactured by Rigid FX Orthopedics, Incorporated. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020311 · Rigid FX Orthopedics, Incorporated · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
90d
Days
Class 2
Risk

K020311 is an FDA 510(k) clearance for the CLEARVIEW WRIST FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Rigid FX Orthopedics, Incorporated (Austin, US). The FDA issued a Cleared decision on April 29, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Rigid FX Orthopedics, Incorporated devices

FDA 510(k) Submission Details - K020311

510(k) Number K020311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2002
Decision Date April 29, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 342
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K020311.
EBI DFS OPTIROM ELBOW FIXATOR
K021312 · Ebi, L.P. · May 2002
EBI XFIX RAIL SYSTEM
K021031 · Ebi, L.P. · May 2002
EBI XFIX DFS SYSTEM
K021091 · Ebi, L.P. · May 2002
MODIFICATION TO EBI XFIX DFS OPTIROM ELBOW FIXATOR
K020403 · Ebi, L.P. · Mar 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K014276 · Ebi, L.P. · Mar 2002
SLIM GLIDING NAIL SYSTEM
K020240 · Plus Orthopedics · Feb 2002