Cleared Traditional

K951357 - EBI SMALL EXTERNAL FIXATOR (S/E/F/)

K951357 is an FDA 510(k) clearance for EBI SMALL EXTERNAL FIXATOR (S/E/F/), 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 89-day FDA review.

K951357 · Electro-Biology, Inc. · Orthopedic device
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Jun 1995
Decision
89d
Days
Class 2
Risk

K951357 is an FDA 510(k) clearance for the EBI SMALL EXTERNAL FIXATOR (S/E/F/). 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 June 21, 1995 after a review of 89 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 - K951357

510(k) Number K951357 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 24, 1995
Decision Date June 21, 1995
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
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 K951357.
EBI X FIX DYNAFIX SYSTEM (DFS)
K953406 · Electro-Biology, Inc. · Oct 1995
INTRAMEDULLARY HIP SCREW (MODIFICATION)
K954712 · Smith & Nephew Richards, Inc. · Oct 1995
GLIDING NAIL
K951809 · Encore Orthopedics, Inc. · Jul 1995
DEPUY COMPRESSION HIP SCREW SYSTEM
K946156 · Depuy, Inc. · May 1995
PEDIATRIC OSTEOTOMY SYSTEM
K945233 · Howmedica Corp. · Feb 1995
HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM
K930836 · Howmedica Corp. · Jan 1995