Cleared Special

K133376 - AEQUALIS HUMERAL NAIL

Also marketed or referenced as:
SIZES 7MM & 8MM X 210, 230, 250, 270MM LEFT AND RIGHT

K133376 is an FDA 510(k) clearance for AEQUALIS HUMERAL NAIL, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 31-day FDA review.

K133376 · Tornier, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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Dec 2013
Decision
31d
Days
Class 2
Risk

K133376 is an FDA 510(k) clearance for the AEQUALIS HUMERAL NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 31 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 Tornier, Inc. devices

FDA 510(k) Submission Details - K133376

510(k) Number K133376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2013
Decision Date December 05, 2013
Days to Decision 31 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
91d faster than avg
Panel avg: 122d · This submission: 31d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

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 497
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K133376.
TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N
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PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131677 · Ellipse Technologies, Inc. · Oct 2013
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K132774 · CarboFix Orthopedics , Ltd. · Oct 2013