Cleared Traditional

K132496 - ARTHROSURFACE TOEMOTION

K132496 · Arthrosurface, Inc. · Orthopedic device
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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

FDA 510(k) Submission Details - K132496

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d slower than avg
Panel avg: 122d · This submission: 201d
Pathway characteristics
Predicate-based equivalence.

LZJ Device Classification - Class 0,

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

Regulatory Peers - LZJ Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained

All 7
Devices cleared under the same product code (LZJ) and FDA review panel - the closest regulatory comparables to K132496.
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM
K072251 · Merete Medical GmbH · May 2008
GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)
K950864 · Acu Med, Inc. · Jul 1995
TOTAL TOE SYSTEM II
K941650 · Biomet, Inc. · Dec 1994
OSTEOMED GREAT TOE SYSTEM
K922211 · Osteomed Corp. · Nov 1993
TOTAL TOE SYSTEM
K920446 · Biomet, Inc. · Mar 1993
GREAT TOE IMPLANT
K920667 · Acu Med, Inc. · Jun 1992