Cleared Traditional

K131377 - HEMICAP MTP RESURFACING HEMI-ARTHROPLAS...

K131377 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 Traditional 510(k) pathway after a 189-day FDA review.

K131377 · Arthrosurface, Inc. · Orthopedic device
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Nov 2013
Decision
189d
Days
Class 2
Risk

K131377 is an FDA 510(k) clearance for the HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT. 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 November 19, 2013 after a review of 189 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

FDA 510(k) Submission Details - K131377

510(k) Number K131377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2013
Decision Date November 19, 2013
Days to Decision 189 days
Submission Type Traditional
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
67d slower than avg
Panel avg: 122d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 22
Devices cleared under the same product code (KWD) and FDA review panel - the closest regulatory comparables to K131377.
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 System
K152454 · Arthrosurface, Inc. · Apr 2016
BIOPRO HEMI-EDGE TOE SYSTEM
K121973 · Biopro, Inc. · Oct 2012
OSTEOMED RESURFACING METATARSAL IMPLANT WITH HYDROXYLAPATITE COATING
K081876 · Osteomed LP · Aug 2008
OSTEOMED METATARSAL RESURFACING IMPLANT SYSTEM
K073065 · Osteomed LP · Feb 2008