Cleared Traditional

K841022 - SRC TOTAL KNEE (FDA 510(k) Clearance)

K841022 · Joint Medical Products Corp. · Orthopedic device
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Jun 1984
Decision
105d
Days
-
Risk

K841022 is an FDA 510(k) clearance for the SRC TOTAL KNEE.

Submitted by Joint Medical Products Corp. (Mchenry, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Joint Medical Products Corp. devices

Submission Details

510(k) Number K841022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 1984
Decision Date June 25, 1984
Days to Decision 105 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -