Cleared Traditional

K101336 - E1 AVANTAGE HEAD

K101336 is an FDA 510(k) clearance for E1 AVANTAGE HEAD, manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K101336 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
247d
Days
Class 2
Risk

K101336 is an FDA 510(k) clearance for the E1 AVANTAGE HEAD. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on January 14, 2011 after a review of 247 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 Manufacturing Corp devices

FDA 510(k) Submission Details - K101336

510(k) Number K101336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2010
Decision Date January 14, 2011
Days to Decision 247 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
125d slower than avg
Panel avg: 122d · This submission: 247d
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 K101336.
MPACT ACETABULAR SYSTEM
K103721 · Medacta International · Mar 2011
ESCALADE ACETABULAR CUP SYSTEM
K103384 · Ortho Development · Mar 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · Smith & Nephew, Inc. · Jan 2011
KLASSIC HD HIP SYSTEM
K100445 · Total Joint Orthopedics, Inc. · Dec 2010
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
K101229 · Zimmer, Inc. · Dec 2010
CONSENSUS TAPERSET HIP SYSTEM
K102399 · Consensus Orthopedics, Inc. · Dec 2010