Cleared Traditional

K972596 - DEPUY DURALOC ACETABULAR CUP SYSTEM

K972596 is an FDA 510(k) clearance for DEPUY DURALOC ACETABULAR CUP SYSTEM, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 124-day FDA review.

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

FDA 510(k) Submission Details - K972596

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.

LPH Device Classification - Class 2, Special Controls

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K972596.
REACH FEMORAL HIP COMPONENT
K971824 · Biomet, Inc. · Dec 1997
FOUNDATION POROUS HIP STEM
K973302 · Encore Orthopedics, Inc. · Dec 1997
ACETABULAR SHELLS WITH MESH INGROWTH SURFACE
K973163 · Howmedica Corp. · Nov 1997
APR POROUS HA HIP SYSTEM
K973124 · Sulzer Orthopedics, Inc. · Nov 1997
SMC ACETABULAR COMPONENT
K971018 · Signal Medical Corp. · Oct 1997
INFINTY DISTAL FEMORAL COMPONENT
K973530 · Wrightmedicaltechnologyinc · Oct 1997