Cleared Special

K161830 - Zimmer M/L Taper Hip Prosthesis

K161830 is an FDA 510(k) clearance for Zimmer M/L Taper Hip Prosthesis, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 113-day FDA review.

K161830 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2016
Decision
113d
Days
Class 2
Risk

K161830 is an FDA 510(k) clearance for the Zimmer M/L Taper Hip Prosthesis. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 26, 2016 after a review of 113 days - within the typical 510(k) review window.

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. 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.

FDA 510(k) Submission Details - K161830

510(k) Number K161830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date October 26, 2016
Days to Decision 113 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
9d faster than avg
Panel avg: 122d · This submission: 113d
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 K161830.
LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated
K161840 · Waldemar Link GmbH & Co. KG · Mar 2017
Revision Femoral Stem
K161226 · Lima Corporate S.P.A. · Feb 2017
Initia Total Hip System & BIOCERAM AZUL(R) HEAD
K160895 · Kyocera Medical Corporation · Nov 2016
Wagner SL Revision Stem Lateral, Wagner Cone Prosthesis® System
K161192 · Zimmer GmbH · Jul 2016
Corin Optimized Positioning System (OPS)
K152893 · Corin USA · Jun 2016
MasterLoc Stem
K160289 · Medacta International · May 2016
K161830 · Zimmer M/L Taper Hip Prosthesis
Download PDF FDA Summary Zimmer, Inc.