Cleared Traditional

K202019 - Maven Patient-Specific Instrumentation (FDA 510(k) Clearance)

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

K202019 · Paragon 28, Inc. · Orthopedic device
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Jan 2021
Decision
177d
Days
Class 2
Risk

K202019 is an FDA 510(k) clearance for the Maven Patient-Specific Instrumentation. Classified as Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer (product code HSN), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on January 14, 2021 after a review of 177 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K202019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2020
Decision Date January 14, 2021
Days to Decision 177 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
55d slower than avg
Panel avg: 122d · This submission: 177d
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

Musculoskeletal Clinical Regulatory Advisers, LLC
Haylie Hertz

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 66
Devices cleared under the same product code (HSN) and FDA review panel - the closest regulatory comparables to K202019.
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K250641 · Paragon 28, Inc. · May 2025
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K242868 · Restor3d · Oct 2024