Cleared Traditional

EBI XFIX OPTIROM KNEE FIXATOR (K031093) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031093 · Ebi, L.P. · Orthopedic device
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Jul 2003
Decision
94d
Days
Class 2
Risk

K031093 is an FDA 510(k) clearance for the EBI XFIX OPTIROM KNEE FIXATOR. 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 July 10, 2003 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ebi, L.P. devices

Submission Details

510(k) Number K031093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2003
Decision Date July 10, 2003
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · This submission: 94d
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 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K031093.
SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES
K033158 · Synthes (Usa) · Nov 2003
EXTERNAL FIXATION SYSTEMS
K031181 · Smith & Nephew, Inc. · Jul 2003
SYNTHES SMALL COBINATION CLAMP-MR SAFE
K031724 · Synthes (Usa) · Jul 2003
SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM
K031725 · Synthes (Usa) · Jun 2003
SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE
K031573 · Synthes (Usa) · Jun 2003
SYNTHES TOMOFIX OSTEOTOMY SYSTEM
K023941 · Synthes (Usa) · Jan 2003