Cleared Traditional

DEPUY DURALOC ACETABULAR CUP SYSTEM (K972596) - FDA 510(k) Clearance

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

K972596 · Depuy, Inc. · Orthopedic device
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Nov 1997
Decision
124d
Days
Class 2
Risk

K972596 is an FDA 510(k) clearance for the DEPUY DURALOC ACETABULAR CUP SYSTEM. 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 November 12, 1997 after a review of 124 days - within the typical 510(k) review window.

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. 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 K972596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1997
Decision Date November 12, 1997
Days to Decision 124 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
2d slower than avg
Panel avg: 122d · This submission: 124d
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 K972596.
VERSYS HIP SYSTEM BEADED HIP PROSTHESIS
K973714 · Zimmer, Inc. · Dec 1997
REACH FEMORAL HIP COMPONENT
K971824 · Biomet, Inc. · Dec 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · Howmedica Corp. · Nov 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997
DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS
K970241 · Depuy, Inc. · Aug 1997
OSTEOLOCK ACETABULAR SHELL SYSTEM
K971854 · Howmedica Corp. · Jul 1997