Cleared Traditional

K072251 - MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM (FDA 510(k) Clearance)

K072251 · Merete Medical GmbH · Orthopedic device
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May 2008
Decision
269d
Days
-
Risk

K072251 is an FDA 510(k) clearance for the MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Merete Medical GmbH (Rye, US). The FDA issued a Cleared decision on May 8, 2008 after a review of 269 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.

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Submission Details

510(k) Number K072251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2007
Decision Date May 08, 2008
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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