Cleared Special

K193030 - Avenir Muller Stem, Avenir Cemented Hip Stem

K193030 is an FDA 510(k) clearance for Avenir Muller Stem, manufactured by Zimmer GmbH. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 37-day FDA review.

K193030 · Zimmer GmbH · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
37d
Days
Class 2
Risk

K193030 is an FDA 510(k) clearance for the Avenir Muller Stem, Avenir Cemented Hip Stem. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on December 6, 2019 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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.

FDA 510(k) Submission Details - K193030

510(k) Number K193030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 2019
Decision Date December 06, 2019
Days to Decision 37 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
85d faster than avg
Panel avg: 122d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 533
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K193030.
Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem
K193050 · Zimmer GmbH · Dec 2019
Acetabular Bone Screws (for MobileLink Acetabular Cup System)
K192559 · Waldemar Link GmbH & Co. KG · Dec 2019
Avenir Complete Hip System, Size 0 Coxa Vara
K192189 · Zimmer, Inc. · Dec 2019
DePuy Corail AMT Hip Prosthesis
K192946 · DePuy Orthopaedics, Inc. · Nov 2019
AMIStem-P Short Neck
K192126 · Medacta International S.A. · Nov 2019
DePuy Corail AMT Hip Prosthesis
K190344 · Depuy(Ireland) · Nov 2019
K193030 · Avenir Muller Stem, Avenir Cemented Hip Stem
Download PDF FDA Summary Zimmer GmbH