Cleared Traditional

K991941 - EBI XFIX DFS RAIL SYSTEM

K991941 is an FDA 510(k) clearance for EBI XFIX DFS RAIL SYSTEM, manufactured by Electro-Biology, Inc.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K991941 · Electro-Biology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
71d
Days
Class 2
Risk

K991941 is an FDA 510(k) clearance for the EBI XFIX DFS RAIL SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Electro-Biology, Inc. (Parsippany, US). The FDA issued a Cleared decision on August 19, 1999 after a review of 71 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 Electro-Biology, Inc. devices

FDA 510(k) Submission Details - K991941

510(k) Number K991941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1999
Decision Date August 19, 1999
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K991941.
SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM
K993289 · Smith & Nephew, Inc. · Dec 1999
EBI XFIX VISION FIXATION SYSTEM
K993886 · Ebi, L.P. · Dec 1999
EBI XFIX DFS WRISTFIX SYSTEM
K993649 · Ebi, L.P. · Nov 1999
EBI XFIX DFS OPTIROM ELBOW FIXATOR
K992515 · Ebi, L.P. · Aug 1999
SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM
K984498 · Synthes (Usa) · Feb 1999
EBI DFS JOINT FIXATOR, MODEL 02800
K981483 · Electro-Biology, Inc. · Jul 1998