Cleared Traditional

APEX HCLA ACETABULAR CUP LINERS (K062489) - FDA 510(k) Clearance

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

K062489 · Omnilife Science · Orthopedic device
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Aug 2007
Decision
355d
Days
Class 2
Risk

K062489 is an FDA 510(k) clearance for the APEX HCLA ACETABULAR CUP LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Omnilife Science (Raynham, US). The FDA issued a Cleared decision on August 15, 2007 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Omnilife Science devices

Submission Details

510(k) Number K062489 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2006
Decision Date August 15, 2007
Days to Decision 355 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
233d slower than avg
Panel avg: 122d · This submission: 355d
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 330
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K062489.
SMITH & NEPHEW MIS HIP STEM
K072417 · Smith & Nephew, Inc. · Jan 2008
DEPUY PINNACLE ALTRX ACETABULAR LINERS
K072963 · DePuy Orthopaedics, Inc. · Jan 2008
REFLECTION, TANDEM UNIPOLAR
K071160 · Smith & Nephew, Inc. · Oct 2007
DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS
K071784 · DePuy Orthopaedics, Inc. · Jul 2007
REGENERX RINGLOC + MODULAR ACETABULAR SHELLS
K070369 · Biomet, Inc. · Mar 2007
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05
K061461 · Zimmer, Inc. · Dec 2006