Cleared Special

K021312 - EBI DFS OPTIROM ELBOW FIXATOR

K021312 is the FDA 510(k) clearance for EBI DFS OPTIROM ELBOW FIXATOR by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 28-day FDA review.

K021312 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
28d
Days
Class 2
Risk

K021312 is an FDA 510(k) clearance for the EBI DFS OPTIROM ELBOW FIXATOR. 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 May 23, 2002 after a review of 28 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 K021312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2002
Decision Date May 23, 2002
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 K021312.
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K012648 · Alliance Medical Corp. · Jun 2002
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · Ebi, L.P. · Jun 2002
OMEGA II SYSTEM
K020772 · Howmedica Osteonics Corp. · Jun 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