Cleared Traditional

K250641 - APEX 3D Total Ankle Replacement System (FDA 510(k) Clearance)

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

K250641 · Paragon 28, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
May 2025
Decision
58d
Days
Class 2
Risk

K250641 is an FDA 510(k) clearance for the APEX 3D Total Ankle Replacement System. 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 May 1, 2025 after a review of 58 days - a notably fast clearance 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: 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K250641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2025
Decision Date May 01, 2025
Days to Decision 58 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
64d faster than avg
Panel avg: 122d · This submission: 58d
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 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 K250641.
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