Cleared Traditional

Cannulated Hemi Implant (K190543) - FDA 510(k) Clearance

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

K190543 · Vilex IN Tennessee, Inc. · Orthopedic device
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May 2019
Decision
88d
Days
Class 2
Risk

K190543 is an FDA 510(k) clearance for the Cannulated Hemi Implant. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Vilex IN Tennessee, Inc. (Mcminnville, US). The FDA issued a Cleared decision on May 31, 2019 after a review of 88 days - a notably fast clearance cycle.

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: 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 Vilex IN Tennessee, Inc. devices

Submission Details

510(k) Number K190543 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2019
Decision Date May 31, 2019
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
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 K190543.
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
restor3d MTP Implant
K201393 · Restor3D, Inc. · May 2022
BioPoly Great Toe Hemiarthroplasty Implant
K203634 · BioPoly, LLC · Feb 2021
Accu-Joint Hemi Implant
K200951 · Accufix Surgical, Inc. · Dec 2020