Cleared Special

K173458 - ORTHOFIX CHIMAERA Hip Fracture System -...

K173458 is the FDA 510(k) clearance for ORTHOFIX CHIMAERA Hip Fracture System -... by Orthofix Srl. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 30-day FDA review.

K173458 · Orthofix Srl · Orthopedic device
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Dec 2017
Decision
30d
Days
Class 2
Risk

K173458 is an FDA 510(k) clearance for the ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Orthofix Srl (Bussolengo, IT). The FDA issued a Cleared decision on December 7, 2017 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Orthofix Srl devices

Submission Details

510(k) Number K173458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2017
Decision Date December 07, 2017
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 Consultant

Wagoner Consulting, LLC
Cheryl Wagoner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 330
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K173458.
T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System
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AUTOBAHN Nailing System
K171108 · Globus Medical, Inc. · Dec 2017
Piccolo Composite Nailing System
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DePuy Synthes Femoral Recon Nail System
K172157 · Synthes USA Products, LLC · Nov 2017
Shotel Ankle Arthrodesis Nail System
K163627 · Biopro, Inc. · Sep 2017
Zimmer Natural Nail System
K172114 · Zimmer, Inc. · Aug 2017