Cleared Traditional

K231496 - TITAN 3-D Wedge System (FDA 510(k) Clearance)

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

K231496 · Paragon 28, Inc. · Orthopedic device
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Aug 2023
Decision
90d
Days
Class 2
Risk

K231496 is an FDA 510(k) clearance for the TITAN 3-D Wedge System. Classified as Bone Wedge (product code PLF), Class II - Special Controls.

Submitted by Paragon 28, Inc. (Englewood, US). The FDA issued a Cleared decision on August 22, 2023 after a review of 90 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 Paragon 28, Inc. devices

Submission Details

510(k) Number K231496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2023
Decision Date August 22, 2023
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PLF Bone Wedge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
Definition Intended To Be Used With Ancillary Fixation For Opening Wedge Osteotomies Or Fusion In The Ankle, Foot, Proximal Tibia.
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 - PLF Bone Wedge

All 17
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K231496.
ATLAS™ Expandable Osteotomy Wedge System
K252733 · MiRus, LLC · Feb 2026
Osteotomy Wedge System
K252254 · Sinaptic Surgical · Oct 2025
Auxano® Wedge Fixation System
K251791 · Auxano Medical, LLC · Sep 2025
OsteoSinter® EVANS and COTTON wedges and related accessories
K240461 · Ames Medical Prosthetic Solutions, S.A.U. · Dec 2024
Trigon PEEK HA Wedges
K243231 · Nvision Biomedical Technologies · Nov 2024
Trigon Trigon HA Stand-Alone Wedge Fixation System
K234116 · Nvision Biomedical Technologies · Jan 2024