Cleared Traditional

K140961 - HOFFMANN LRF (LIMB RECONSTRUCTION FRAME...

K140961 is an FDA 510(k) clearance for HOFFMANN LRF (LIMB RECONSTRUCTION FRAME..., manufactured by Stryker Trauma AG. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 209-day FDA review.

K140961 · Stryker Trauma AG · Orthopedic device
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Nov 2014
Decision
209d
Days
Class 2
Risk

K140961 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 Trauma AG (Selzach, CH). The FDA issued a Cleared decision on November 10, 2014 after a review of 209 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 Stryker Trauma AG devices

FDA 510(k) Submission Details - K140961

510(k) Number K140961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2014
Decision Date November 10, 2014
Days to Decision 209 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
87d slower than avg
Panel avg: 122d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

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 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K140961.
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