Cleared Traditional

K920446 - TOTAL TOE SYSTEM (FDA 510(k) Clearance)

K920446 · Biomet, Inc. · Orthopedic device
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Mar 1993
Decision
412d
Days
-
Risk

K920446 is an FDA 510(k) clearance for the TOTAL TOE SYSTEM. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 22, 1993 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K920446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 04, 1992
Decision Date March 22, 1993
Days to Decision 412 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
290d slower than avg
Panel avg: 122d · This submission: 412d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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