Cleared Special

ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 (K031572) - FDA 510(k) Clearance

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

K031572 · Zimmer, Inc. · Orthopedic device
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Jun 2003
Decision
35d
Days
Class 2
Risk

K031572 is an FDA 510(k) clearance for the ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923. 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 June 24, 2003 after a review of 35 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 K031572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2003
Decision Date June 24, 2003
Days to Decision 35 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
87d faster than avg
Panel avg: 122d · This submission: 35d
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 K031572.
GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
K032581 · Howmedica Osteonics Corp. · Oct 2003
MALLORY/HEAD TOTAL HIP SYSTEM
K030055 · Biomet, Inc. · Aug 2003
MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA
K031693 · Biomet, Inc. · Aug 2003
HA PMI FLANGED ACETABULAR COMPONENT
K030861 · Biomet, Inc. · Jun 2003
PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS
K031495 · DePuy Orthopaedics, Inc. · Jun 2003
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · Zimmer, Inc. · May 2003