Cleared Traditional

K150867 - Affixus Tibial Nailing System

K150867 is the FDA 510(k) clearance for Affixus Tibial Nailing System by Biomet, Inc.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K150867 · Biomet, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2015
Decision
70d
Days
Class 2
Risk

K150867 is an FDA 510(k) clearance for the Affixus Tibial Nailing System. 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 June 10, 2015 after a review of 70 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet, Inc. devices

Submission Details

510(k) Number K150867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2015
Decision Date June 10, 2015
Days to Decision 70 days
Submission Type Traditional
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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 330
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K150867.
Piccolo Composite® Nailing System
K153536 · CarboFix Orthopedics , Ltd. · Jan 2016
Cardinal Health Trochanteric IM Nail System
K150769 · Cardinalhealth · Dec 2015
Piccolo Composite Nailing System
K151010 · CarboFix Orthopedics , Ltd. · Jul 2015
ITST Intertrochanteric/Subtrochanteric Fixation System
K143321 · Zimmer, Inc. · May 2015
MICRONAIL Distal Radius System
K150073 · Wrightmedicaltechnologyinc · Feb 2015
Acumed Small Bone IM Nail System
K143276 · Acumed, LLC · Feb 2015