Cleared Traditional

K052239 - EBI DYNAFIX VISION FOOTPLATE SYSTEM

K052239 is an FDA 510(k) clearance for EBI DYNAFIX VISION FOOTPLATE SYSTEM, manufactured by Ebi, L.P.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K052239 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
35d
Days
Class 2
Risk

K052239 is an FDA 510(k) clearance for the EBI DYNAFIX VISION FOOTPLATE 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 September 21, 2005 after a review of 35 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

FDA 510(k) Submission Details - K052239

510(k) Number K052239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 2005
Decision Date September 21, 2005
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 362
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K052239.
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R&R EXTERNAL FIXATION SYSTEM
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K052062 · Alliance Medical Corp. · Aug 2005