Cleared Special

K152454 - HemiCAP MTP Resurfacing Hemi-Arthroplas...

K152454 is an FDA 510(k) clearance for HemiCAP MTP Resurfacing Hemi-Arthroplas..., manufactured by Arthrosurface, Inc.. The device is a Class 2 Orthopedic device with product code KWD cleared through the Special 510(k) pathway after a 227-day FDA review.

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

FDA 510(k) Submission Details - K152454

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 122d · This submission: 227d
Pathway characteristics
Modification to existing cleared device.

KWD Device Classification - Class 2, Special Controls

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 24
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K152454.
BOSS Toe Fixation System
K190261 · Arthrosurface, Inc. · Aug 2019
Cannulated Hemi Implant
K190543 · Vilex IN Tennessee, Inc. · May 2019
Life Spine Metatarsal Hemi Implant
K161279 · Life Spine, Inc. · Feb 2017
HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT
K131377 · Arthrosurface, Inc. · Nov 2013
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · Biopro, Inc. · Oct 2012
ASCENSION METAL GREAT TOE SYSTEM
K092047 · Ascension Orthopedics, Inc. · Jan 2010