Cleared Traditional

K122208 - EXTERNAL FIXATOR SYSTEM

K122208 is an FDA 510(k) clearance for EXTERNAL FIXATOR SYSTEM, manufactured by Christopher D. Endara. The device is a Class 2 Orthopedic device with product code NDK cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K122208 · Christopher D. Endara · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
148d
Days
Class 2
Risk

K122208 is an FDA 510(k) clearance for the EXTERNAL FIXATOR SYSTEM. Classified as System, External Fixator (with Metallic Invasive Components) (product code NDK), Class II - Special Controls.

Submitted by Christopher D. Endara (Miami, US). The FDA issued a Cleared decision on December 20, 2012 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 Christopher D. Endara devices

FDA 510(k) Submission Details - K122208

510(k) Number K122208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date December 20, 2012
Days to Decision 148 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
26d slower than avg
Panel avg: 122d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NDK Device Classification - Class 2, Special Controls

Product Code NDK System, External Fixator (with Metallic Invasive Components)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - NDK System, External Fixator (with Metallic Invasive Components)

Devices cleared under the same product code (NDK) and FDA review panel - the closest regulatory comparables to K122208.
TRIMED X-FIX
K101375 · TriMed, Inc. · Sep 2010