Cleared Traditional

K113327 - HOFFMANN LRF (LIMB RECONSTRUCTION FRAME...

K113327 is the FDA 510(k) clearance for HOFFMANN LRF (LIMB RECONSTRUCTION FRAME... by Stryker Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K113327 · Stryker Corp. · Orthopedic device
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Mar 2012
Decision
140d
Days
Class 2
Risk

K113327 is an FDA 510(k) clearance for the HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Stryker Corp. (Mahwah, US). The FDA issued a Cleared decision on March 29, 2012 after a review of 140 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 Stryker Corp. devices

Submission Details

510(k) Number K113327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2011
Decision Date March 29, 2012
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 278
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K113327.
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K112218 · DePuy Orthopaedics, Inc. · Dec 2011
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K110069 · Smith & Nephew, Inc. · Feb 2011