Cleared Special

K170072 - Fitmore Hip Stem

K170072 is the FDA 510(k) clearance for Fitmore Hip Stem by Zimmer GmbH. It is a Class 2 Orthopedic device (product code KWY) cleared through the Special 510(k) pathway after a 29-day FDA review.

K170072 · Zimmer GmbH · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2017
Decision
29d
Days
Class 2
Risk

K170072 is an FDA 510(k) clearance for the Fitmore® Hip Stem. Classified as Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (product code KWY), Class II - Special Controls.

Submitted by Zimmer GmbH (Winterthur, CH). The FDA issued a Cleared decision on February 7, 2017 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3390 - 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 GmbH devices

Submission Details

510(k) Number K170072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2017
Decision Date February 07, 2017
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3390
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 - KWY Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

All 74
Devices cleared under the same product code (KWY) and FDA review panel - the closest regulatory comparables to K170072.
SurgTech Bipolar Head System
K173455 · Surgtech, Inc. · Jun 2018
ELEOS™ Bipolar Acetabular System
K180130 · Onkos Surgical, Inc. · Feb 2018
40-42mm BiPolar Head and 22mm Femoral Head
K163081 · Signature Orthopaedics Pty, Ltd. · Jan 2018
U2 Bipolar Implant and 22mm Femoral Head
K152439 · United Orthopedic Corporation · Apr 2016
BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP
K112019 · Corentec Co., Ltd. · Oct 2011
BIOPRO POLAR HEAD
K100761 · Biopro, Inc. · Dec 2010