Cleared Traditional

FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control (K151992) - FDA 510(k) Clearance

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

K151992 · Zimmer, Inc. · Orthopedic device
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Nov 2015
Decision
105d
Days
Class 2
Risk

K151992 is an FDA 510(k) clearance for the FastFrame External Fixation System - Knee Spanning, FastFrame External Fixati.... Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 2, 2015 after a review of 105 days - within the typical 510(k) review window.

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 Zimmer, Inc. devices

Submission Details

510(k) Number K151992 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 2015
Decision Date November 02, 2015
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 174
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K151992.
FastFrame External Fixation System-Ankle Spanning
K152755 · Zimmer, Inc. · Dec 2015
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K152484 · Zimmer, Inc. · Dec 2015
RX-FIX Mini Rail External Fixator
K150640 · Wrightmedicaltechnologyinc · Dec 2015
SALVATION® External Fixation System
K152045 · Wrightmedicaltechnologyinc · Aug 2015
Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System
K150818 · Zimmer, Inc. · May 2015
SALVATION External Fixation System
K150004 · Wrightmedicaltechnologyinc · Mar 2015