Cleared Traditional

FOUNDATION POROUS ACETABULAR SYSTEM (K973119) - FDA 510(k) Clearance

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

K973119 · Encore Orthopedics, Inc. · Orthopedic device
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Jan 1998
Decision
161d
Days
Class 2
Risk

K973119 is an FDA 510(k) clearance for the FOUNDATION POROUS ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on January 28, 1998 after a review of 161 days - an extended review cycle.

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 Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K973119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1997
Decision Date January 28, 1998
Days to Decision 161 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 122d · This submission: 161d
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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K973119.
DEPUY TRI-LOCK HIP STEM
K974740 · Depuy, Inc. · Mar 1998
MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING
K971206 · Howmedica Corp. · Feb 1998
UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM
K974331 · Johnson & Johnson Professionals, Inc. · Feb 1998
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