Cleared Traditional

K132496 - ARTHROSURFACE TOEMOTION (FDA 510(k) Clearance)

K132496 · Arthrosurface, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
201d
Days
-
Risk

K132496 is an FDA 510(k) clearance for the ARTHROSURFACE TOEMOTION. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Arthrosurface, Inc. (Franklin, US). The FDA issued a Cleared decision on February 26, 2014 after a review of 201 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel. 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 K132496 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2013
Decision Date February 26, 2014
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZJ Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Device Class -