Cleared Special

K020240 - SLIM GLIDING NAIL SYSTEM

K020240 is an FDA 510(k) clearance for SLIM GLIDING NAIL SYSTEM, manufactured by Plus Orthopedics. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 30-day FDA review.

K020240 · Plus Orthopedics · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
30d
Days
Class 2
Risk

K020240 is an FDA 510(k) clearance for the SLIM GLIDING NAIL SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Plus Orthopedics (San Diego, US). The FDA issued a Cleared decision on February 22, 2002 after a review of 30 days - a notably fast clearance 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. 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 Plus Orthopedics devices

FDA 510(k) Submission Details - K020240

510(k) Number K020240 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2002
Decision Date February 22, 2002
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 287
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K020240.
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
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K020141 · Ebi, L.P. · Feb 2002
MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM
K014194 · Ebi, L.P. · Jan 2002
EBI XFIX ACCESS PELVIC FIXATOR
K013540 · Ebi, L.P. · Nov 2001