Cleared Traditional

K190261 - BOSS Toe Fixation System (FDA 510(k) Clearance)

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

K190261 · Arthrosurface, Inc. · Orthopedic device
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Aug 2019
Decision
187d
Days
Class 2
Risk

K190261 is an FDA 510(k) clearance for the BOSS Toe Fixation System. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on August 14, 2019 after a review of 187 days - an extended review 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: 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 Arthrosurface, Inc. devices

Submission Details

510(k) Number K190261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 08, 2019
Decision Date August 14, 2019
Days to Decision 187 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d slower than avg
Panel avg: 122d · This submission: 187d
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 K190261.
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