Cleared Traditional

K111678 - ORTHO SOLUTIONS EXTREMITY FIXATION IMPL...

K111678 is an FDA 510(k) clearance for ORTHO SOLUTIONS EXTREMITY FIXATION IMPL..., manufactured by Ortho Solutions Limited. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K111678 · Ortho Solutions Limited · Orthopedic device
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Feb 2012
Decision
237d
Days
Class 2
Risk

K111678 is an FDA 510(k) clearance for the ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESIS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Ortho Solutions Limited (Prior Lake, US). The FDA issued a Cleared decision on February 7, 2012 after a review of 237 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 Ortho Solutions Limited devices

FDA 510(k) Submission Details - K111678

510(k) Number K111678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2011
Decision Date February 07, 2012
Days to Decision 237 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
115d slower than avg
Panel avg: 122d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1046
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K111678.
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
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TRAUMA INTERNAL FIXATION SYSTEMS
K111663 · DePuy Orthopaedics, Inc. · Mar 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · Synthes USA Products, LLC · Feb 2012
CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM
K113762 · Arthrosurface, Inc. · Feb 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014 · Wrightmedicaltechnologyinc · Jan 2012
MAXLOCK EXTREME SYSTEM
K113048 · Orthohelix Surgical Designs, Inc. · Jan 2012