Cleared Traditional

K152974 - ORTHOLOC® 3Di Foot Plating Reconstruction System

K152974 is an FDA 510(k) clearance for ORTHOLOC 3Di Foot Plating Reconstructio..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K152974 · Wrightmedicaltechnologyinc · Orthopedic device
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Dec 2015
Decision
64d
Days
Class 2
Risk

K152974 is an FDA 510(k) clearance for the ORTHOLOC® 3Di Foot Plating Reconstruction 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 Wrightmedicaltechnologyinc (Memphis, US). The FDA issued a Cleared decision on December 11, 2015 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K152974

510(k) Number K152974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2015
Decision Date December 11, 2015
Days to Decision 64 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 122d · This submission: 64d
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 1245
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K152974.
OsteoMed ExtremiLOCK Wrist Plating System
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AXI+LINE Proximal Bunion Correction System
K152548 · Nextremity Solutions, Inc. · Dec 2015
MotoBand¿ CP Implant System
K152306 · Crossroads Extremity Systems, LLC · Dec 2015
AOS Small Fragment Plating System
K152732 · Avanced Orthopaedic Solutions, Inc. (Aos) · Dec 2015
NET Brand Small Fragment and Large Fragment Osteosynthesis Plating System, NET Brand of DHS/DCS Plating System
K150561 · Narang Medical Limited · Nov 2015
SMV Scientific Bone Plate and Screw System
K152000 · Smv Scientific · Nov 2015