Cleared Special

K111041 - MINI VARIABLE SYSTEM

K111041 is an FDA 510(k) clearance for MINI VARIABLE 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 53-day FDA review.

K111041 · Orthohelix Surgical Designs, Inc. · Orthopedic device
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Jun 2011
Decision
53d
Days
Class 2
Risk

K111041 is an FDA 510(k) clearance for the MINI VARIABLE 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 June 6, 2011 after a review of 53 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 - K111041

510(k) Number K111041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2011
Decision Date June 06, 2011
Days to Decision 53 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
69d faster than avg
Panel avg: 122d · This submission: 53d
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
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K111041.
VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES
K110670 · Smith & Nephew, Inc. · Jul 2011
APTUS FOOT 3.5 SYSTEM
K110908 · Medartis AG · Jun 2011
ORTHOPEDIATRICS FRACTURE AND OSTEOTOMY BONE PLATE SYSTEM
K111086 · OrthoPediatrics Corp. · Jun 2011
ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM
K111039 · Zimmer, Inc. · May 2011
2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM
K110125 · Synthes (Usa) · Apr 2011
AXSOS (TM) LOCKING PLATE SYSTEM
K110476 · Stryker Corp. · Mar 2011