Cleared Special

K211313 - MAXFRAME Multi-Axial Correction System (aka MAXFRAME)

K211313 is an FDA 510(k) clearance for MAXFRAME Multi-Axial Correction System ..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code KTT cleared through the Special 510(k) pathway after a 25-day FDA review.

K211313 · Synthes USA Products, LLC · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2021
Decision
25d
Days
Class 2
Risk

K211313 is an FDA 510(k) clearance for the MAXFRAME Multi-Axial Correction System (aka MAXFRAME). Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on May 25, 2021 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K211313

510(k) Number K211313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2021
Decision Date May 25, 2021
Days to Decision 25 days
Submission Type Special
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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 404
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K211313.
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K202833 · Sequel Medical, Inc. · Jan 2021
K211313 · MAXFRAME Multi-Axial Correction System (aka MAXFRAME)
Download PDF FDA Summary Synthes USA Products,…