Cleared Traditional

POROCOAT POROUS COATING (K931641) - FDA 510(k) Clearance

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

K931641 · Depuy, Inc. · Orthopedic device
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Mar 1994
Decision
353d
Days
Class 2
Risk

K931641 is an FDA 510(k) clearance for the POROCOAT POROUS COATING. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 21, 1994 after a review of 353 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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. Elevated predicate reliance profile. 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 K931641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date March 21, 1994
Days to Decision 353 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
231d slower than avg
Panel avg: 122d · This submission: 353d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K931641.
HOWMEDICA ACETABULAR SHELL W/SCREW HOLES
K933102 · Howmedica Corp. · May 1994
TRILOGY ACETABULAR SYSTEM
K934765 · Zimmer, Inc. · Apr 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · Depuy, Inc. · Apr 1994
ACETABULAR SHELL
K935731 · Howmedica Corp. · Mar 1994
HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM
K921308 · Zimmer, Inc. · Feb 1994
BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT
K921557 · Zimmer, Inc. · Feb 1994