Cleared Traditional

K031859 - CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT (FDA 510(k) Clearance)

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

K031859 · Arthrosurface, Inc. · Orthopedic device
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Feb 2004
Decision
247d
Days
Class 2
Risk

K031859 is an FDA 510(k) clearance for the CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT. Classified as Prosthesis, Toe, Hemi-, Phalangeal (product code KWD), Class II - Special Controls.

Submitted by Arthrosurface, Inc. (Stoughton, US). The FDA issued a Cleared decision on February 18, 2004 after a review of 247 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 K031859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date February 18, 2004
Days to Decision 247 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
125d slower than avg
Panel avg: 122d · This submission: 247d
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 K031859.
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