Cleared Traditional

K070444 - AOS TIBIAL NAIL

K070444 is an FDA 510(k) clearance for AOS TIBIAL NAIL, manufactured by Advanced Orthopaedic Solutions, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K070444 · Advanced Orthopaedic Solutions, Inc. · Orthopedic device
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Jun 2007
Decision
119d
Days
Class 2
Risk

K070444 is an FDA 510(k) clearance for the AOS TIBIAL 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 June 14, 2007 after a review of 119 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Advanced Orthopaedic Solutions, Inc. devices

FDA 510(k) Submission Details - K070444

510(k) Number K070444 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 2007
Decision Date June 14, 2007
Days to Decision 119 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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K070444.
ACID ETCHED LAG SCREWS
K070955 · Biomet Orthopedics, Inc. · Oct 2007
BIOMET FEMORAL LOCKING NAIL SYSTEM
K072161 · Biomet Manufacturing Corp · Sep 2007
ACUMED SMALL BONE LOCKING SYSTEM II
K071944 · Acumed, LLC · Aug 2007
SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM
K070843 · Synthes (Usa) · May 2007
SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES
K070294 · Synthes (Usa) · Mar 2007
BIOMET TIBIAL LOCKING NAIL SYSTEM
K063570 · Biomet Manufacturing Corp · Feb 2007