Cleared Traditional

K050327 - E-POLY (VITAMIN E) ACETABULAR LINERS

K050327 is an FDA 510(k) clearance for E-POLY (VITAMIN E) ACETABULAR LINERS, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 230-day FDA review.

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

FDA 510(k) Submission Details - K050327

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.

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 K050327.
ESKA-LIBUR HIP STEM
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K052026 · Wrightmedicaltechnologyinc · Dec 2005
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K051556 · Exactech, Inc. · Sep 2005
TRABECULAR METAL PRIMARY HIP PROSTHESIS
K051491 · Zimmer, Inc. · Jun 2005
TRABECULAR METAL ACETABULAR REVISION SHELLS
K050937 · Zimmer Trabecular · May 2005