Cleared Special

K103662 - CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS

Also marketed or referenced as:
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LI

K103662 is an FDA 510(k) clearance for CONTINUUM AND TRILOGY INTEGRATED TAPER ..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Special 510(k) pathway after a 121-day FDA review.

K103662 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2011
Decision
121d
Days
Class 2
Risk

K103662 is an FDA 510(k) clearance for the CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on April 15, 2011 after a review of 121 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K103662

510(k) Number K103662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2010
Decision Date April 15, 2011
Days to Decision 121 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
1d faster than avg
Panel avg: 122d · This submission: 121d
Pathway characteristics
Modification to existing cleared device.

LPH Device Classification - Class 2, Special Controls

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 543
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K103662.
COREN TOTAL HIP SYSTEM
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TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072 · Howmedica Osteonics Corp. · Apr 2011
CONSENSUS BIOLOX DELTA CERAMIC FEMORAL HEAD
K110542 · Consensus Orthopedics, Inc. · Apr 2011
ARCOMXL ACTIVE ARTICULATION
K110555 · Biomet Manufacturing Corp · Mar 2011