Cleared Special

K183162 - Affixus Hip Fracture Nail

K183162 is the FDA 510(k) clearance for Affixus Hip Fracture Nail by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Special 510(k) pathway after a 29-day FDA review.

K183162 · Biomet, Inc. · Orthopedic device
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Dec 2018
Decision
29d
Days
Class 2
Risk

K183162 is an FDA 510(k) clearance for the Affixus Hip Fracture Nail. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 14, 2018 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Biomet, Inc. devices

Submission Details

510(k) Number K183162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2018
Decision Date December 14, 2018
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 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 Peers - HSB Rod, Fixation, Intramedullary And Accessories

All 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K183162.
Estremo Citieffe Nailing System
K181540 · Citieffe S.R.L. · Jan 2019
Small Bone Phantom® Intramedullary Nail System
K182307 · Paragon 28, Inc. · Jan 2019
Affixus Natural Nail System Humeral Nail
K181827 · Zimmer GmbH · Dec 2018
Panta 2 Arthrodesis Nail System
K181639 · Integra LifeSciences Corporation · Nov 2018
OsteoBridge™ IDSF System
K181026 · Merete GmbH · Oct 2018
X-BOLT Hip Fracture Fixation System
K181640 · X-Bolt Orthopaedics · Oct 2018