Cleared Traditional

MODIFIED PROFILE FEMORAL HIP (K870213) - FDA 510(k) Clearance

K870213 · Depuy, Inc. · Orthopedic device
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Feb 1987
Decision
17d
Days
-
Risk

K870213 is an FDA 510(k) clearance for the MODIFIED PROFILE FEMORAL HIP.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 17 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.

View all Depuy, Inc. devices

Submission Details

510(k) Number K870213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1987
Decision Date February 06, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 122d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -