Cleared Traditional

K830004 - POROCOAT DUAL-LOCK TOTAL HIP SYSTEM

K830004 is an FDA 510(k) clearance for POROCOAT DUAL-LOCK TOTAL HIP SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 106-day FDA review.

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

FDA 510(k) Submission Details - K830004

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.

JDI Device Classification - Class 2, Special Controls

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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K830004.
LUS ACETABULAR COMPONENT
K830209 · Biomet, Inc. · May 1983
HARRIS A.R. C. ACETABULAR CUP
K830857 · Howmedica Corp. · May 1983
CEMENTED 101 32 FEMORAL COMPONENT
K830750 · Intermedics Orthopedics · May 1983
SPECTRON PROXIMAL FEMORAL PROSTHESIS
K823723 · Richard'S Medical Equip., Inc. · Mar 1983
SPECTRON NECK REPLACEMENT PROSTHESIS
K823724 · Richard'S Medical Equip., Inc. · Mar 1983
TITANIUM M.E. MULLER TYPE TOTAL HIP
K830356 · Boehringer Mannheim Corp. · Mar 1983