Cleared Special

K133081 - TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N

K133081 is an FDA 510(k) clearance for TROCHANTERIC NAILS AND ES TROCHANTERIC ..., manufactured by Advanced Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 92-day FDA review.

K133081 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
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Dec 2013
Decision
92d
Days
Class 2
Risk

K133081 is an FDA 510(k) clearance for the TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, AN.... Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on December 31, 2013 after a review of 92 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Advanced Orthopaedic Solutions, Inc. devices

FDA 510(k) Submission Details - K133081

510(k) Number K133081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date December 31, 2013
Days to Decision 92 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
30d faster than avg
Panel avg: 122d · This submission: 92d
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 460
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K133081.
SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM
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ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K131490 · Ellipse Technologies, Inc. · Jan 2014
DISTALOCK TIBIAL IM NAIL SYSTEM
K132830 · Dgimed Ortho, Inc. · Jan 2014
IDEAL
K132428 · Jiangsu Ideal Medical Science & Technology Co., LT · Dec 2013
PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM
K133289 · Ellipse Technologies, Inc. · Dec 2013
AEQUALIS HUMERAL NAIL
K133376 · Tornier, Inc. · Dec 2013