Cleared Traditional

K163650 - ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension

K163650 is an FDA 510(k) clearance for ORTHOLOC 3Di Ankle Fusion Plating Syste..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K163650 · Wrightmedicaltechnologyinc · Orthopedic device
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Apr 2017
Decision
122d
Days
Class 2
Risk

K163650 is an FDA 510(k) clearance for the ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension. 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 April 24, 2017 after a review of 122 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K163650

510(k) Number K163650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 2016
Decision Date April 24, 2017
Days to Decision 122 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
At panel average
Panel avg: 122d · This submission: 122d
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 1235
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K163650.
Colink™ Plating System
K163293 · In2bones USA, LLC · May 2017
Locking Plate System
K162380 · Beijing Keyi Medical Device Technology Co., Ltd. · May 2017
Pantheon Medical Balanced Plating System
K162154 · Pantheon Medical · Apr 2017
EVOS Small Fragment Plating System
K170887 · Smith & Nephew, Inc. · Apr 2017
GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND Of DHS/Dynamic Condylar Plate Plating System
K163383 · Greens Surgicals Pvt. , Ltd. · Apr 2017
Additive Orthopaedics Locking Lattice Plate
K170214 · Additive Orthopaedics, LLC · Apr 2017