Cleared Traditional

Quantum® Total Ankle Prosthesis (K191380) - FDA 510(k) Clearance

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

K191380 · In2bones Sas · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jan 2020
Decision
251d
Days
Class 2
Risk

K191380 is an FDA 510(k) clearance for the Quantum® Total Ankle Prosthesis. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by In2bones Sas (Ecully, FR). The FDA issued a Cleared decision on January 29, 2020 after a review of 251 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3110 - 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 In2bones Sas devices

Submission Details

510(k) Number K191380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2019
Decision Date January 29, 2020
Days to Decision 251 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
129d slower than avg
Panel avg: 122d · This submission: 251d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3110
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 Consultant

In2bones USA
Christine Scifert

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HSN Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer

All 55
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K191380.
Kinos Axiom Total Ankle System
K192778 · Kinos Medical · Jun 2020
Cadence Total Ankle System
K201507 · Integra LifeSciences Corporation · Jun 2020
The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System
K193067 · Wrightmedicaltechnologyinc · Jun 2020
INFINITY Total Ankle System, INBONE Total Ankle System
K191393 · Wrightmedicaltechnologyinc · Aug 2019
Vantage Total Ankle Flat Cut Talar Components
K183343 · Exactech, Inc. · Apr 2019
Integra Salto Total Ankle System
K182878 · Ascension Orthopedics · Dec 2018