Cleared Special

K132591 - MAXLOCK EXTREME SYSTEM

K132591 is an FDA 510(k) clearance for MAXLOCK EXTREME SYSTEM, manufactured by Orthohelix Surgical Designs, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 29-day FDA review.

K132591 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Sep 2013
Decision
29d
Days
Class 2
Risk

K132591 is an FDA 510(k) clearance for the MAXLOCK EXTREME SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Orthohelix Surgical Designs, Inc. (Medina, US). The FDA issued a Cleared decision on September 17, 2013 after a review of 29 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.

View all Orthohelix Surgical Designs, Inc. devices

FDA 510(k) Submission Details - K132591

510(k) Number K132591 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2013
Decision Date September 17, 2013
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
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 - HRS Plate, Fixation, Bone

All 1005
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