Cleared Traditional

K884561 - KOENIG TOTAL TOE IMPLANT (FDA 510(k) Clearance)

K884561 · Dow Corning Wright · Orthopedic device
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Jan 1989
Decision
85d
Days
-
Risk

K884561 is an FDA 510(k) clearance for the KOENIG TOTAL TOE IMPLANT. Classified as Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained (product code LZJ).

Submitted by Dow Corning Wright (Arlington, US). The FDA issued a Cleared decision on January 24, 1989 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K884561 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 31, 1988
Decision Date January 24, 1989
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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