Cleared Traditional

K102549 - THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY

K102549 · Ascension Orthopedics, Inc. · Orthopedic device
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Dec 2010
Decision
105d
Days
-
Risk

K102549 is an FDA 510(k) clearance for the THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Ascension Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on December 21, 2010 after a review of 105 days - within the typical 510(k) review window.

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 Ascension Orthopedics, Inc. devices

FDA 510(k) Submission Details - K102549

510(k) Number K102549 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 2010
Decision Date December 21, 2010
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
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 9
Devices cleared under the same product code (LZJ) and FDA review panel - the closest regulatory comparables to K102549.
ARTHROSURFACE TOEMOTION
K132496 · Arthrosurface, Inc. · Feb 2014
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
KINETIK GREAT TOE SYSTEM
K924724 · Kinetikos Medical, Inc. · Jan 1994
OSTEOMED GREAT TOE SYSTEM
K922211 · Osteomed Corp. · Nov 1993