Cleared Special

K011711 - MODIFICATION TO EBI EFIX VISION FIXATIO...

K011711 is the FDA 510(k) clearance for MODIFICATION TO EBI EFIX VISION FIXATIO... by Ebi, L.P.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 25-day FDA review.

K011711 · Ebi, L.P. · Orthopedic device
Download Printable Device Report (PDF)
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Jun 2001
Decision
25d
Days
Class 2
Risk

K011711 is an FDA 510(k) clearance for the MODIFICATION TO EBI EFIX 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 June 29, 2001 after a review of 25 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 K011711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2001
Decision Date June 29, 2001
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
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 K011711.
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR
K013503 · DePuy Orthopaedics, Inc. · Nov 2001
EBI XFIX DFS SYSTEM
K013378 · Ebi, L.P. · Nov 2001
EBI XFIX DFS SYSTEM
K012024 · Ebi, L.P. · Jul 2001
SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM
K011034 · Synthes (Usa) · Jun 2001
EBI XFIX ACCESS PELVIC FIXATOR
K011697 · Ebi, L.P. · Jun 2001
SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE
K010766 · Synthes (Usa) · Jun 2001