Cleared Traditional

E-POLY (VITAMIN E) ACETABULAR LINERS (K050327) - FDA 510(k) Clearance

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

K050327 · Biomet, Inc. · Orthopedic device
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Sep 2005
Decision
230d
Days
Class 2
Risk

K050327 is an FDA 510(k) clearance for the E-POLY (VITAMIN E) ACETABULAR LINERS. 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 September 27, 2005 after a review of 230 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 K050327 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2005
Decision Date September 27, 2005
Days to Decision 230 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
108d slower than avg
Panel avg: 122d · This submission: 230d
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 K050327.
DEPUY MODULAR M HEADS
K060031 · DePuy Orthopaedics, Inc. · Jan 2006
LINEAGE A-CLASS POLY LINER
K052026 · Wrightmedicaltechnologyinc · Dec 2005
ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS
K052255 · Biomet, Inc. · Nov 2005
ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE
K051556 · Exactech, Inc. · Sep 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491 · Zimmer, Inc. · Jun 2005
RX90 LOW PROFILE ACETABULAR SYSTEM
K042989 · Biomet, Inc. · Apr 2005