Cleared Traditional

K201393 - restor3d MTP Implant (FDA 510(k) Clearance)

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

K201393 · Restor3D, Inc. · Orthopedic device
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May 2022
Decision
728d
Days
Class 2
Risk

K201393 is an FDA 510(k) clearance for the restor3d MTP Implant. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Restor3D, Inc. (Durham, US). The FDA issued a Cleared decision on May 25, 2022 after a review of 728 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3730 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Restor3D, Inc. devices

Submission Details

510(k) Number K201393 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2020
Decision Date May 25, 2022
Days to Decision 728 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
606d slower than avg
Panel avg: 122d · This submission: 728d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWD Prosthesis, Toe, Hemi-, Phalangeal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3730
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 - KWD Prosthesis, Toe, Hemi-, Phalangeal

All 44
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K201393.
Accu-Joint Hemi Implant
K240268 · Accufix Surgical, Inc. · Feb 2024
Montross Extremity Medical Hemi Implant System
K221220 · Montross Extremity Medical · Apr 2023
BioPoly Lesser Toe Hemiarthroplasty Implant
K222964 · BioPoly, LLC · Nov 2022
BioPoly Great Toe Hemiarthroplasty Implant
K203634 · BioPoly, LLC · Feb 2021