Cleared Traditional

K941048 - TRUE/LOK MONOLATERAL/BILATERAL FIXATOR

K941048 is an FDA 510(k) clearance for TRUE/LOK MONOLATERAL/BILATERAL FIXATOR, manufactured by Applied Osteo Systems, Inc.. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K941048 · Applied Osteo Systems, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K941048

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.

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 53
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K941048.
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K950384 · Synthes (Usa) · May 1995
MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM
K864403 · Howmedica Corp. · Dec 1986