Cleared Special

K040833 - MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM

K040833 is an FDA 510(k) clearance for MODIFICATION TO EBI XFIX VISION FIXATIO..., manufactured by Ebi, L.P.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 29-day FDA review.

K040833 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
29d
Days
Class 2
Risk

K040833 is an FDA 510(k) clearance for the MODIFICATION TO EBI XFIX VISION FIXATION 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 April 29, 2004 after a review of 29 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

FDA 510(k) Submission Details - K040833

510(k) Number K040833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2004
Decision Date April 29, 2004
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 K040833.
OMEGA 2 SYSTEM
K041001 · Howmedica Osteonics Corp. · Jul 2004
FRAGMENT PLATE SYSTEM, SCREWS, PINS AND K-WIRES
K041081 · Hand Innovations, Inc. · Jul 2004
VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES
K031687 · Vanguard Medical Concepts, Inc. · Apr 2004
SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE
K040258 · Synthes (Usa) · Mar 2004
3.5 MM LCP DISTAL HUMERUS SYSTEM
K033995 · Synthes (Usa) · Mar 2004
MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM
K033476 · Howmedica Osteonics Corp. · Jan 2004