Cleared Traditional

K062997 - ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS

K062997 is an FDA 510(k) clearance for ARCOMXL POLYETHYLENE LINERS AND 38/40MM..., manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code LZO cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K062997 · Biomet Manufacturing Corp · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
67d
Days
Class 2
Risk

K062997 is an FDA 510(k) clearance for the ARCOMXL POLYETHYLENE LINERS AND 38/40MM FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on December 8, 2006 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K062997

510(k) Number K062997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date December 08, 2006
Days to Decision 67 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
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 510
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K062997.
EXACTECH NOVATION CROWN CUP AND LINERS
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K063616 · Howmedica Osteonics Corp. · Dec 2006
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K062748 · DePuy Orthopaedics, Inc. · Nov 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · Exactech, Inc. · Nov 2006
EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD
K062684 · Aesculap, Inc. · Nov 2006