Cleared Special

HemiCAP MTP Resurfacing Hemi-Arthroplasty System

K152454 · Arthrosurface, Inc. · Orthopedic
Apr 2016
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K152454 is an FDA 510(k) clearance for the HemiCAP MTP Resurfacing Hemi-Arthroplasty System, a Prosthesis, Toe, Hemi-, Phalangeal (Class II — Special Controls, product code KWD), submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on April 11, 2016, 227 days after receiving the submission on August 28, 2015. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3730.

Submission Details

510(k) Number K152454 FDA.gov
FDA Decision Cleared 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

Device Classification

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

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