Cleared Traditional

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

K870213 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 -