Cleared Traditional

K060072 - MONOBLOCK PRESS-FIT HIP STEM

K060072 is the FDA 510(k) clearance for MONOBLOCK PRESS-FIT HIP STEM by Omni Life Science, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K060072 · Omni Life Science, Inc. · Orthopedic device
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Aug 2006
Decision
227d
Days
Class 2
Risk

K060072 is an FDA 510(k) clearance for the MONOBLOCK PRESS-FIT HIP STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Omni Life Science, Inc. (Raynham, US). The FDA issued a Cleared decision on August 24, 2006 after a review of 227 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 Omni Life Science, Inc. devices

Submission Details

510(k) Number K060072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2006
Decision Date August 24, 2006
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
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 445
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K060072.
FMP COATED SPIKED ACETABULAR CUP
K063257 · Encore Medical, L.P. · Nov 2006
TRIDENT LARGE DIAMETER ACETABULAR INSERTS
K062419 · Howmedica Osteonics Corp. · Nov 2006
DEPUY PINNACLE ALTRX ACETABULAR CUP LINER
K062148 · DePuy Orthopaedics, Inc. · Oct 2006
TRIDENT LARGE DIAMETER HIP SYSTEM
K061434 · Howmedica Osteonics Corp. · Aug 2006
TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE
K061226 · Zimmer, Inc. · Aug 2006
VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS
K061786 · Zimmer, Inc. · Jul 2006