Cleared Traditional

K830185 - UNIV. KNEE, CUTTING INSTRUMENTATION (FDA 510(k) Clearance)

K830185 · Intermedics Orthopedics · General & Plastic Surgery device
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Mar 1983
Decision
49d
Days
-
Risk

K830185 is an FDA 510(k) clearance for the UNIV. KNEE, CUTTING INSTRUMENTATION.

Submitted by Intermedics Orthopedics (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 49 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery 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.

View all Intermedics Orthopedics devices

Submission Details

510(k) Number K830185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1983
Decision Date March 09, 1983
Days to Decision 49 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 114d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -