Cleared Traditional

K120359 - ORTHOLOC 3DI HALLUX SYSTEM

K120359 is the FDA 510(k) clearance for ORTHOLOC 3DI HALLUX SYSTEM by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K120359 · Wrightmedicaltechnologyinc · Orthopedic device
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May 2012
Decision
87d
Days
Class 2
Risk

K120359 is an FDA 510(k) clearance for the ORTHOLOC 3DI HALLUX 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 (Arlington, US). The FDA issued a Cleared decision on May 3, 2012 after a review of 87 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

Submission Details

510(k) Number K120359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2012
Decision Date May 03, 2012
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 928
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K120359.
SYNTHES 3.5 MM VA-LCP PROXIMAL TIBIA PLATE SYSTEM
K120689 · Synthes USA Products, LLC · Jun 2012
EOS SMALL BONE FIXATION SYSTEM
K112794 · TriMed, Inc. · May 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES)
K120717 · Synthes (Usa) · May 2012
APTUS PROXIMAL HUMERUS SYSTEM
K120108 · Medartis AG · Apr 2012
VARIAX SUPERIOR AND ANTERIOR, LATERAL AND MIDSHAFT CLAVICLE PLATES VARIAX AIMING BLOCKS & JOYSTICK
K113760 · Howmedica Osteonics Corp., Dba Stryker Orthopaedics · Apr 2012
OSTEOMED WRIST PLATING SYSTEM
K120015 · Osteomed LP · Apr 2012