Cleared Traditional

K914078 - DEPUY HIP PROSTHESIS

K914078 is the FDA 510(k) clearance for DEPUY HIP PROSTHESIS by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 484-day FDA review.

K914078 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
484d
Days
Class 2
Risk

K914078 is an FDA 510(k) clearance for the DEPUY HIP PROSTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 7, 1993 after a review of 484 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - the FDA orthopedic device regulatory framework. 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. Elevated predicate reliance 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 Depuy, Inc. devices

Submission Details

510(k) Number K914078 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date January 07, 1993
Days to Decision 484 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
362d slower than avg
Panel avg: 122d · This submission: 484d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K914078.
TECHMEDICA CAD/CAM CUSTOM HIP
K911058 · Techmedica, Inc. · Feb 1993
THE UNIVERSAL BONE CEMENT RESISTOR
K924323 · Biodynamic Technologies, Inc. · Feb 1993
PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP
K922733 · Orthomet, Inc. · Feb 1993
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K920739 · Joint Medical Products Corp. · Nov 1992
LESTER PRESS FIT HIP PROSTHESIS
K915500 · Kirschner Medical Corp. · Oct 1992
KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP
K922421 · Kinamed, Inc. · Oct 1992