Cleared Traditional

K063370 - CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY

K063370 is an FDA 510(k) clearance for CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY, 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 65-day FDA review.

K063370 · Arthrosurface, Inc. · Orthopedic device
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Jan 2007
Decision
65d
Days
Class 2
Risk

K063370 is an FDA 510(k) clearance for the CAP 7.0MM MTP RESURFACING HEMI-ARTHROPLASTY. 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 January 12, 2007 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Arthrosurface, Inc. devices

FDA 510(k) Submission Details - K063370

510(k) Number K063370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date January 12, 2007
Days to Decision 65 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
57d faster than avg
Panel avg: 122d · This submission: 65d
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 K063370.
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
ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS
K063058 · Arthrex, Inc. · Jan 2007
OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM
K060536 · Osteomed LP · Jun 2006
TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870
K041595 · Biopro, Inc. · Nov 2004