Cleared Special

K152454 - HemiCAP MTP Resurfacing Hemi-Arthroplasty System (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152454 · Arthrosurface, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
227d
Days
Class 2
Risk

K152454 is an FDA 510(k) clearance for the HemiCAP MTP Resurfacing Hemi-Arthroplasty 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 April 11, 2016 after a review of 227 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Arthrosurface, Inc. devices

Submission Details

510(k) Number K152454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2015
Decision Date April 11, 2016
Days to Decision 227 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Modification to existing cleared device.

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 K152454.
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