Cleared Traditional

K030372 - MODIFICATION TO EBI DYNAFIX DIAPHYSEAL ...

K030372 is the FDA 510(k) clearance for MODIFICATION TO EBI DYNAFIX DIAPHYSEAL ... by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K030372 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2003
Decision
30d
Days
Class 2
Risk

K030372 is an FDA 510(k) clearance for the MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION 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 March 6, 2003 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. 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 K030372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 2003
Decision Date March 06, 2003
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
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 K030372.
EBI XFIX DFS SYSTEM
K031645 · Ebi, L.P. · Jun 2003
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SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · Synthes (Usa) · Jun 2003
REPROCESSED EXTERNAL FIXATION DEVICE
K023714 · Alliance Medical Corp. · Feb 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · Synthes (Usa) · Jan 2003
MODIFICATION TO EBI XFIX DFS SYSTEM METAPHYSEAL CORRECTION SYSTEM
K024248 · Ebi, L.P. · Jan 2003