Cleared Traditional

K230067 - Para-Fix External Fixation System

K230067 is an FDA 510(k) clearance for Para-Fix External Fixation System, manufactured by New Paradigm Biomedical. The device is a Class 2 Orthopedic device with product code LXT cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K230067 · New Paradigm Biomedical · Orthopedic device
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Sep 2023
Decision
256d
Days
Class 2
Risk

K230067 is an FDA 510(k) clearance for the Para-Fix External Fixation System. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component, Metal Composite (product code LXT), Class II - Special Controls.

Submitted by New Paradigm Biomedical (Needham, US). The FDA issued a Cleared decision on September 22, 2023 after a review of 256 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 New Paradigm Biomedical devices

FDA 510(k) Submission Details - K230067

510(k) Number K230067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2023
Decision Date September 22, 2023
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
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 34
Devices cleared under the same product code (LXT) and FDA review panel - the closest regulatory comparables to K230067.
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