Cleared Special

ZIMMER ANATOMIC II HIP PROSTHESIS (K041109) - FDA 510(k) Clearance

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

K041109 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
83d
Days
Class 2
Risk

K041109 is an FDA 510(k) clearance for the ZIMMER ANATOMIC II HIP PROSTHESIS. 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 July 20, 2004 after a review of 83 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 Zimmer, Inc. devices

Submission Details

510(k) Number K041109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2004
Decision Date July 20, 2004
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K041109.
ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING
K042337 · Zimmer, Inc. · Nov 2004
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
K042776 · Zimmer, Inc. · Nov 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · Exactech, Inc. · Sep 2004
DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062
K040544 · Depuy, Inc. · May 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · DePuy Orthopaedics, Inc. · May 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
K033273 · DePuy Orthopaedics, Inc. · May 2004