Cleared Traditional

RX90 LOW PROFILE ACETABULAR SYSTEM (K042989) - FDA 510(k) Clearance

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

K042989 · Biomet, Inc. · Orthopedic device
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Apr 2005
Decision
181d
Days
Class 2
Risk

K042989 is an FDA 510(k) clearance for the RX90 LOW PROFILE ACETABULAR SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 28, 2005 after a review of 181 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 Biomet, Inc. devices

Submission Details

510(k) Number K042989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date April 28, 2005
Days to Decision 181 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
59d slower than avg
Panel avg: 122d · This submission: 181d
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 K042989.
E-POLY (VITAMIN E) ACETABULAR LINERS
K050327 · Biomet, Inc. · Sep 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556 · Exactech, Inc. · Sep 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491 · Zimmer, Inc. · Jun 2005
ARCOMXL POLYETHYLENE LINERS
K042051 · Biomet, Inc. · Mar 2005
TRIDENT ACETABULAR SYSTEM
K033716 · Howmedica Osteonics Corp. · Feb 2005
MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS
K042774 · Biomet, Inc. · Jan 2005