Cleared Traditional

K924724 - KINETIK GREAT TOE SYSTEM (FDA 510(k) Clearance)

K924724 · Kinetikos Medical, Inc. · Orthopedic device
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Jan 1994
Decision
471d
Days
-
Risk

K924724 is an FDA 510(k) clearance for the KINETIK GREAT TOE SYSTEM. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Kinetikos Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 471 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 Kinetikos Medical, Inc. devices

Submission Details

510(k) Number K924724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 1992
Decision Date January 05, 1994
Days to Decision 471 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
349d slower than avg
Panel avg: 122d · This submission: 471d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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