Cleared Traditional

K101375 - TRIMED X-FIX

K101375 is an FDA 510(k) clearance for TRIMED X-FIX, manufactured by TriMed, Inc.. The device is a Class 2 Orthopedic device with product code NDK cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K101375 · TriMed, Inc. · Orthopedic device
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Sep 2010
Decision
121d
Days
Class 2
Risk

K101375 is an FDA 510(k) clearance for the TRIMED X-FIX. Classified as System, External Fixator (with Metallic Invasive Components) (product code NDK), Class II - Special Controls.

Submitted by TriMed, Inc. (Saugus, US). The FDA issued a Cleared decision on September 15, 2010 after a review of 121 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 TriMed, Inc. devices

FDA 510(k) Submission Details - K101375

510(k) Number K101375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2010
Decision Date September 15, 2010
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
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.