Cleared Special

K022319 - EBI XFIX DFS SYSTEM

K022319 is the FDA 510(k) clearance for EBI XFIX DFS SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 26-day FDA review.

K022319 · Ebi, L.P. · Orthopedic device
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Aug 2002
Decision
26d
Days
Class 2
Risk

K022319 is an FDA 510(k) clearance for the EBI XFIX DFS SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Ebi, L.P. (Parsippany, US). The FDA issued a Cleared decision on August 12, 2002 after a review of 26 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 Ebi, L.P. devices

Submission Details

510(k) Number K022319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2002
Decision Date August 12, 2002
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
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 282
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K022319.
EBI XFIX DFS SYSTEM
K023399 · Ebi, L.P. · Oct 2002
MODIFICATION TO EBI XFIX DFS SYSTEM
K023324 · Ebi, L.P. · Oct 2002
TEMPFIX EXTERNAL FIXATION SYSTEM
K021933 · DePuy Orthopaedics, Inc. · Aug 2002
REPROCESSED EXTERNAL FIXATION DEVICE
K012623 · Alliance Medical Corp. · Jun 2002
REPROCESSED HOWMEDICA EXTERNAL FIXATION DEVICES
K012648 · Alliance Medical Corp. · Jun 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · Ebi, L.P. · Jun 2002