Cleared Traditional

Ankle Fusion Plating System (K173121) - FDA 510(k) Clearance

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

K173121 · In2bones Sas · Orthopedic device
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Nov 2017
Decision
60d
Days
Class 2
Risk

K173121 is an FDA 510(k) clearance for the Ankle Fusion Plating 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 In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on November 28, 2017 after a review of 60 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 In2bones Sas devices

Submission Details

510(k) Number K173121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2017
Decision Date November 28, 2017
Days to Decision 60 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
62d faster than avg
Panel avg: 122d · This submission: 60d
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 701
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K173121.
EVOS Small Fragment Upper Extremity Plates
K173293 · Smith & Nephew, Inc. · Jan 2018
Alians Elbow Locking Plating System
K171372 · Newclip Technics · Jan 2018
Life Spine Foot and Ankle Plating System
K172973 · Life Spine, Inc. · Dec 2017
ANTHEM Fracture System
K173166 · Globus Medical, Inc. · Nov 2017
DARCO Locking Bone Plate System
K171852 · Wrightmedicaltechnologyinc · Sep 2017
Arthrex Mesh Plate System
K170547 · Arthrex, Inc. · Sep 2017