Cleared Traditional

K950384 - SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR

K950384 is an FDA 510(k) clearance for SYNTHES(USA) SYNTHES HYBRID EXTERNAL FI..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K950384

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.

LXT Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K950384.
TITANIUM UNIVERSAL CLAMP
K960269 · Synthes (Usa) · Apr 1996
ACE-DUPONT COMPOSITE RINGS
K955388 · Ace Medical Co. · Jan 1996
HEX-FIX FIELD FIXATOR
K953397 · Smith & Nephew Richards, Inc. · Oct 1995
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · Howmedica Corp. · Dec 1986