Cleared Traditional

K102549 - THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTY (FDA 510(k) Clearance)

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

Submission Details

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
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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