Cleared Special

CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS (K103662) - FDA 510(k) Clearance

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

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

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

Submission Details

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.

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 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K103662.
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
TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE
K101072 · Howmedica Osteonics Corp. · Apr 2011
SMITH & NEPHEW SMF HIP STEM
K103256 · Smith & Nephew, Inc. · Jan 2011
LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER
K101229 · Zimmer, Inc. · Dec 2010