Cleared Traditional

K973119 - FOUNDATION POROUS ACETABULAR SYSTEM

K973119 is an FDA 510(k) clearance for FOUNDATION POROUS ACETABULAR SYSTEM, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K973119 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K973119

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
Combination Product No
PCCP Authorized No
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.

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 446
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
FOUNDATION POROUS COATED HEMISPHERICAL SHELL
K974093 · Encore Orthopedics, Inc. · Jan 1998
FOUNDATION POROUS COATED FLARED RIM SHELL
K974095 · Encore Orthopedics, Inc. · Jan 1998
ENCORE LINEAR POROUS COATED HIP
K974294 · Encore Orthopedics, Inc. · Jan 1998