Cleared Traditional

K021031 - EBI XFIX RAIL SYSTEM

K021031 is the FDA 510(k) clearance for EBI XFIX RAIL SYSTEM by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K021031 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
48d
Days
Class 2
Risk

K021031 is an FDA 510(k) clearance for the EBI XFIX RAIL 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 May 16, 2002 after a review of 48 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ebi, L.P. devices

Submission Details

510(k) Number K021031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2002
Decision Date May 16, 2002
Days to Decision 48 days
Submission Type Traditional
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
74d faster than avg
Panel avg: 122d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K021031.
EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM
K021695 · Ebi, L.P. · Jun 2002
OMEGA II SYSTEM
K020772 · Howmedica Osteonics Corp. · Jun 2002
EBI DFS OPTIROM ELBOW FIXATOR
K021312 · 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