Cleared Traditional

K111993 - FRAMEWALKER

K111993 is an FDA 510(k) clearance for FRAMEWALKER, manufactured by Quantum Medical Concepts, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K111993 · Quantum Medical Concepts, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
103d
Days
Class 2
Risk

K111993 is an FDA 510(k) clearance for the FRAMEWALKER. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Quantum Medical Concepts, LLC (Portland, US). The FDA issued a Cleared decision on October 24, 2011 after a review of 103 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.

FDA 510(k) Submission Details - K111993

510(k) Number K111993 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2011
Decision Date October 24, 2011
Days to Decision 103 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
19d faster than avg
Panel avg: 122d · This submission: 103d
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 394
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K111993 · FRAMEWALKER
Download PDF FDA Summary Quantum Medical Conce…