Cleared Traditional

K950384 - SYNTHES(USA) SYNTHES HYBRID EXTERNAL FI...

K950384 is the FDA 510(k) clearance for SYNTHES(USA) SYNTHES HYBRID EXTERNAL FI... by Synthes (Usa). It is a Class 2 Orthopedic device (product code LXT) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K950384 · Synthes (Usa) · Orthopedic device
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May 1995
Decision
110d
Days
Class 2
Risk

K950384 is an FDA 510(k) clearance for the SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 110 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 Synthes (Usa) devices

Submission Details

510(k) Number K950384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date May 22, 1995
Days to Decision 110 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
12d faster than avg
Panel avg: 122d · This submission: 110d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite
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 - LXT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite

All 33
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K950384.
BERLIN EXTERNAL FIXATOR
K954053 · Encore Orthopedics, Inc. · May 1996
TITANIUM UNIVERSAL CLAMP
K960269 · Synthes (Usa) · Apr 1996
HEX-FIX FIELD FIXATOR
K953397 · Smith & Nephew Richards, Inc. · Oct 1995
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · Howmedica Corp. · Dec 1986