Cleared Traditional

Restor3d Utility Wedge (K201314) - FDA 510(k) Clearance

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

K201314 · Restor3D, Inc. · Orthopedic device
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Jun 2021
Decision
395d
Days
Class 2
Risk

K201314 is an FDA 510(k) clearance for the Restor3d Utility Wedge. Classified as Bone Wedge (product code PLF), Class II - Special Controls.

Submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on June 17, 2021 after a review of 395 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Restor3D, Inc. devices

Submission Details

510(k) Number K201314 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date June 17, 2021
Days to Decision 395 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
273d slower than avg
Panel avg: 122d · This submission: 395d
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 13
Devices cleared under the same product code (PLF) and FDA review panel - the closest regulatory comparables to K201314.
TITAN 3-D Wedge System
K231496 · Paragon 28, Inc. · Aug 2023
Trigon™ HA Stand-Alone Wedge Fixation System
K223226 · Nvision Biomedical Technologies, Inc. · Dec 2022
Trigon HA Wedge Fixation System
K220197 · Nvision Biomedical Technologies, Inc. · Feb 2022
Trigon HA Stand-Alone Wedge Fixation System
K203445 · Nvision Biomedical Technologies, Inc. · Dec 2020
Trigon HA Stand-Alone Wedge Fixation System
K193414 · Nvision Biomedical Technologies, Inc. · Feb 2020
Trigon™ Ti Stand-Alone Wedge Fixation System
K192645 · Nvision Biomedical Technologies, Inc. · Dec 2019