Cleared Traditional

K093753 - MDPO FRAME SYSTEM

K093753 is an FDA 510(k) clearance for MDPO FRAME SYSTEM, manufactured by Mdpo, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 262-day FDA review.

K093753 · Mdpo, LLC · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2010
Decision
262d
Days
Class 2
Risk

K093753 is an FDA 510(k) clearance for the MDPO FRAME SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Mdpo, LLC (Alexandria, US). The FDA issued a Cleared decision on August 26, 2010 after a review of 262 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 Mdpo, LLC devices

FDA 510(k) Submission Details - K093753

510(k) Number K093753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 2009
Decision Date August 26, 2010
Days to Decision 262 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
140d slower than avg
Panel avg: 122d · This submission: 262d
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 316
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K093753.
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SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES
K100137 · Wrightmedicaltechnologyinc · Jun 2010
SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS
K092190 · Synthes (Usa) · May 2010
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL
K090658 · Synthes (Usa) · Mar 2010