Cleared Traditional

K163650 - ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K163650 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Wrightmedicaltechnologyinc devices

Submission Details

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
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.

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 1306
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K163650.
OrthoPediatrics® Locking Cannulated Blade Plate System
K260323 · OrthoPediatrics Corp. · Apr 2026
PC Fix System
K260411 · Chest Wall Innovations, Inc. · Apr 2026
POYA 3.5mm Medial Proximal Tibia System
K260228 · Bonebridge AG · Apr 2026
I.T.S. PRS Phoenix II
K260054 · I.T.S. GmbH · Apr 2026
SMART Osteotomy System
K260090 · Actis Medical Pty., Ltd. · Apr 2026
enHAnce PEEK Bunion System
K253718 · Nvision Biomedical Technologies, Inc. · Apr 2026