Cleared Special

K122244 - POLARCUP DUAL MOBILITY SYSTEM

K122244 is the FDA 510(k) clearance for POLARCUP DUAL MOBILITY SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code LPH) cleared through the Special 510(k) pathway after a 27-day FDA review.

K122244 · Smith & Nephew, Inc. · Orthopedic device
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Aug 2012
Decision
27d
Days
Class 2
Risk

K122244 is an FDA 510(k) clearance for the POLARCUP DUAL MOBILITY SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on August 23, 2012 after a review of 27 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K122244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2012
Decision Date August 23, 2012
Days to Decision 27 days
Submission Type Special
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
95d faster than avg
Panel avg: 122d · This submission: 27d
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 442
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K122244.
NOVATION LPI PRIME FEMORAL STEM
K121684 · Exactech, Inc. · Oct 2012
ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER
K113296 · Zimmer, Inc. · Sep 2012
BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG
K120924 · Corentec Co., Ltd. · Sep 2012
TAPERLOC COMPLETE SIZE 4MM AND XR 123
K120030 · Biomet Manufacturing Corp · Aug 2012
HIP SYSTEMS
K121308 · Howmedica Osteonics Corp. · Jul 2012
LINEAR POROUS COATED HIP STEM, SIZE 5
K121024 · Encore Medical, L.P. · Jun 2012