Cleared Traditional

K920188 - THREADED PINS (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K920188 · Kirschner Medical Corp. · Orthopedic device
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May 1993
Decision
483d
Days
Class 3
Risk

K920188 is an FDA 510(k) clearance for the THREADED PINS. Classified as Fastener, Fixation, Biodegradable, Hard Tissue (product code MBJ), Class III - Premarket Approval.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 483 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. High regulatory complexity 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 Kirschner Medical Corp. devices

Submission Details

510(k) Number K920188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1992
Decision Date May 12, 1993
Days to Decision 483 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
361d slower than avg
Panel avg: 122d · This submission: 483d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MBJ Fastener, Fixation, Biodegradable, Hard Tissue
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.