Cleared Special

K090478 - AOS PROXIMAL HUMERAL NAIL

K090478 is an FDA 510(k) clearance for AOS PROXIMAL HUMERAL NAIL, 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 30-day FDA review.

K090478 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
30d
Days
Class 2
Risk

K090478 is an FDA 510(k) clearance for the AOS PROXIMAL HUMERAL NAIL. 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 March 26, 2009 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.

FDA 510(k) Submission Details - K090478

510(k) Number K090478 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 2009
Decision Date March 26, 2009
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.

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 529
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K090478.
ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM
K090596 · Zimmer, Inc. · Jun 2009
SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS)
K090241 · Synthes (Usa) · Jun 2009
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL
K083648 · Efratgo, Ltd. HI Tech Bio-Surgical · May 2009
PEDINAIL INTRAMEDULLARY NAILING SYSTEM
K083726 · OrthoPediatrics Corp. · Mar 2009
ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS
K083497 · Zimmer, Inc. · Feb 2009
INTRAMEDULLARY FIXATION ROD (IFS)
K083458 · Novalign Orthopaedics, Inc. · Feb 2009
K090478 · AOS PROXIMAL HUMERAL NAIL
Download PDF FDA Summary Advanced Orthopaedic …