Cleared Special

K120802 - ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLO...

K120802 is the FDA 510(k) clearance for ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLO... by Wrightmedicaltechnologyinc. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 17-day FDA review.

K120802 · Wrightmedicaltechnologyinc · Orthopedic device
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Apr 2012
Decision
17d
Days
Class 2
Risk

K120802 is an FDA 510(k) clearance for the ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS. 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 April 2, 2012 after a review of 17 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 Wrightmedicaltechnologyinc devices

Submission Details

510(k) Number K120802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2012
Decision Date April 02, 2012
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Modification to existing cleared device.

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 K120802.
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
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
K120667 · Smith & Nephew, Inc. · Apr 2012
SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM
K120070 · Synthes (Usa) · Mar 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663 · DePuy Orthopaedics, Inc. · Mar 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · Synthes USA Products, LLC · Feb 2012