Cleared Traditional

TRUE/LOK MONOLATERAL/BILATERAL FIXATOR (K941048) - FDA 510(k) Clearance

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

K941048 · Applied Osteo Systems, Inc. · Orthopedic device
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Oct 1994
Decision
210d
Days
Class 2
Risk

K941048 is an FDA 510(k) clearance for the TRUE/LOK MONOLATERAL/BILATERAL FIXATOR. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by Applied Osteo Systems, Inc. (Walnut Creek, US). The FDA issued a Cleared decision on October 3, 1994 after a review of 210 days - an extended review 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: 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 Applied Osteo Systems, Inc. devices

Submission Details

510(k) Number K941048 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1994
Decision Date October 03, 1994
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 27
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K941048.
SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF)
K963618 · Synthes (Usa) · Nov 1996
TITANIUM UNIVERSAL CLAMP
K960269 · Synthes (Usa) · Apr 1996
SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR
K950384 · Synthes (Usa) · May 1995
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · Howmedica Corp. · Dec 1986