Cleared Special

APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM) (K112779) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K112779 · Omnlife Science · Orthopedic device
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Dec 2011
Decision
67d
Days
Class 2
Risk

K112779 is an FDA 510(k) clearance for the APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM). Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Omnlife Science (East Taunton, US). The FDA issued a Cleared decision on December 2, 2011 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Omnlife Science devices

Submission Details

510(k) Number K112779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2011
Decision Date December 02, 2011
Days to Decision 67 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 122d · This submission: 67d
Pathway characteristics
Modification to existing cleared device.

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K112779.
POLARCUP DUAL MOBILITY SYSTEM
K122244 · Smith & Nephew, Inc. · Aug 2012
HIP SYSTEMS
K121308 · Howmedica Osteonics Corp. · Jul 2012
NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5
K113609 · Exactech, Inc. · Jan 2012
POLARCUP DUAL MOBILITY SYSTEM
K110135 · Smith & Nephew, Inc. · Oct 2011
CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS
K103662 · Zimmer, Inc. · Apr 2011
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072 · Howmedica Osteonics Corp. · Apr 2011