Cleared Traditional

POROCOAT DUAL-LOCK TOTAL HIP SYSTEM (K830004) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830004 · Depuy, Inc. · Orthopedic device
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Apr 1983
Decision
106d
Days
Class 2
Risk

K830004 is an FDA 510(k) clearance for the POROCOAT DUAL-LOCK TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1983 after a review of 106 days - within the typical 510(k) review window.

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: 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 Depuy, Inc. devices

Submission Details

510(k) Number K830004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1983
Decision Date April 19, 1983
Days to Decision 106 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
16d faster than avg
Panel avg: 122d · This submission: 106d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K830004.
CFE TOTAL HIP FEMORAL COMPONENT
K830313 · Biomet, Inc. · May 1983
LUS ACETABULAR COMPONENT
K830209 · Biomet, Inc. · May 1983
HARRIS A.R. C. ACETABULAR CUP
K830857 · Howmedica Corp. · May 1983
TITANIUM M.E. MULLER TYPE TOTAL HIP
K830356 · Boehringer Mannheim Corp. · Mar 1983
HC 1M METALBACKED ACETABULAR CUP
K823419 · Osteonics Corp. · Jan 1983
ZIMMER METAL BACKED ACETABULAR CUP
K821893 · Zimmer, Inc. · Sep 1982