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ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

US

Last updated May 24, 2026

What ADVANCED ORTHOPAEDIC SOLUTIONS, INC. makes

Advanced Orthopaedic Solutions, Inc. manufactures orthopaedic fixation devices, including non-bioabsorbable bone screws, femur and tibia nails, internal fixation plates and screws, and external fixation systems. Their product line also covers surgical tools such as aiming arms, reusable implantation sleeves, and reusable surgical connectors, as well as specific instruments like retractors and depth gauges.

The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable regulatory requirements for orthopaedic hardware.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Advanced Orthopaedic Solutions, Inc. primarily manufacture?

Advanced Orthopaedic Solutions, Inc. specializes in orthopaedic fixation devices, including non-bioabsorbable bone screws, femur and tibia nails, internal fixation systems (plates and screws), and external fixation systems. Their product line also extends to surgical tools like orthopaedic aiming arms, reusable implantation sleeves, and reusable surgical connectors, as well as specific instruments such as retractors and depth gauges. These devices are designed to support bone stabilization and fracture repair.

Where is Advanced Orthopaedic Solutions, Inc. based, and what regulatory framework does it follow?

Advanced Orthopaedic Solutions, Inc. is based in the United States. As a manufacturer, it develops devices in compliance with U.S. regulatory requirements, including those governing orthopaedic hardware. Individual devices are classified under FDA’s regulatory categories, ensuring they meet applicable standards for safety and performance.

Are Advanced Orthopaedic Solutions, Inc.’s devices listed in any regulatory registries, and if so, which ones?

Yes, Advanced Orthopaedic Solutions, Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices by assigning a standardized identifier, ensuring transparency and traceability for regulatory and market surveillance purposes.

How are Advanced Orthopaedic Solutions, Inc.’s devices classified under FDA regulations?

Advanced Orthopaedic Solutions, Inc.’s devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body part it interacts with.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
US
Address
—
Website
aosortho.com
LinkedIn
—
Facebook
—
Phone
(310) 533-9966
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
117858154

Catalogue (3113)

Page 34 of 63
DeviceModel / ReferenceRegistriesClassStatus
Suprapatellar Tibial Entry Sheath 0642-000
FDA UDI
Class IIActive
MODULAR FLEXIBLE REAMER HEAD, Ø11.5mm 0234-115
FDA UDI
Class IIActive
AOS CORTICAL SCREW 5.0mm x 105mm 8000-105
FDA UDI
Class IIActive
AOS HUMERAL NAIL 9mm x 32.5cm S1173-325
FDA UDI
Class IIUnknown
Semi-Tubular Plate, 5-Hole 3060-005
FDA UDI
Class IIActive
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD3.5mm x 12mm 8114-012
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 36cm x 130° 1123-365
FDA UDI
Class IIActive
Cannulated Drill, 2.5mm, Ankle Plate 4010
FDA UDI
Class IActive
Galileo® Lag Screw Inserter 0454-100
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 135mm 8040-135
FDA UDI
Class IIActive
AOS TIBIAL NAIL 13mm x 27.0cm S1113-270
FDA UDI
Class IIUnknown
AOS CAPTURED CORTICAL SCREW 4.2mm x 85mm S8002-085
FDA UDI
Class IIUnknown
AOS HUMERAL NAIL 7mm x 25.0cm S1171-250
FDA UDI
Class IIUnknown
AOS CAPTURED CORTICAL SCREW 5.0mm x 55mm S8001-055
FDA UDI
Class IIUnknown
AOS CAPTURED CORTICAL SCREW 5.0mm x 26mm S8001-026
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 30cm x 130° S1058-305
FDA UDI
Class IIUnknown
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 40cm S1309-040
FDA UDI
Class IIUnknown
9/32 Hex Driver, Cannulated, Large Hudson 0475-000
FDA UDI
Class IIActive
Compression Sleeve 0410-100
FDA UDI
Class IActive
CORTICAL SCREW 3.5mm x 26.0mm 8010-260
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 125mm 8040-125
FDA UDI
Class IIActive
AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 1mm 1047-019
FDA UDI
Class IIActive
Torque Limiting Mini Axial Handle, 1.7Nm 5024
FDA UDI
Class IActive
Non-Locking Screw, 3.5mm x 30mm 8084-030
FDA UDI
Class IIActive
Non-Locking Screw, 4.0mm x 46mm 8085-046
FDA UDI
Class IIActive
Variable Angle Locking Screw, 3.5mm x 24mm 8088-024
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 40mm 8001-040
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 24mm S8001-024
FDA UDI
Class IIUnknown
HEX SCREW DRIVER, AO STYLE 2.5mm 0459-100
FDA UDI
Class IActive
Non-Locking Screw, 4.0mm x 50mm 8085-050
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL, LEFT 12.5mm x 36cm x 130° 1122-360
FDA UDI
Class IIActive
AOS TIBIAL NAIL 13mm x 31.5cm S1113-315
FDA UDI
Class IIUnknown
Minimally Invasive Calcaneal Plate, Left, Small 3076-020
FDA UDI
Class IIActive
Semi-Tubular Plate, 9-Hole 3060-009
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 80mm 8081-080
FDA UDI
Class IIActive
ES™ TROCHANTERIC NAIL, LEFT, Ø11mm x 45cm x 125° 1022-455
FDA UDI
Class IIActive
AOS CALIBRATED DRILL (AO STYLE) 4.8mm 0287
FDA UDI
Class IActive
Reduction Bolt, Insertion Guide Tibial Nail 1237
FDA UDI
Class IActive
Aos Lateral Superior Clavicle Plate Medium, Right 3004-040
FDA UDI
Class IIActive
AOS HUMERAL NAIL 8.0mm x 22.5cm 1172-225
FDA UDI
Class IIActive
Entry Sheath 0638
FDA UDI
Class IActive
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 125mm 1045-125
FDA UDI
Class IIActive
Non-Locking Screw, 4.0mm x 28mm 8085-028
FDA UDI
Class IIActive
Bending Template, Minimally Invasive Calcaneus Plate, Medium 0549-040
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 42cm 1311-042
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 11mm x 26cm 1341-026
FDA UDI
Class IIActive
AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 90mm 1335-090
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW 4.0mm x 48mm 8023-048
FDA UDI
Class IIActive
GALILEO® LAG SCREW, LEFT, 10.5mm x 85mm 1199-085
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 36cm x 130° 1069-365
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

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Authorities

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FDA Recalls (12)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Advanced Orthopaedic Solutions, Inc. has 12 recall records, all initiated on January 14, 2010, with each listed as terminated. The recalls were prompted by a manufacturing defect involving the short Trochanteric Nail, specifically where one component was found to be incorrectly bent. The reason cited noted that, if the issue recurred, surgery time could potentially be extended due to the need for nail exchanges.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

DateRecall No.ClassStatusReason
Jan 14, 2010Z-1182-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1190-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1188-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1187-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1186-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1184-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-118-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1191-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1189-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1183-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1181-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.

Jan 14, 2010Z-1192-2010—terminated

The recall was initiated after Advanced Orthopaedic Solutions (AOS) became aware of a manufacturing defect involving the short Trochanteric Nail, where one piece was found to be incorrectly bent. If this issue were to recur, surgery time could be extended, but only slightly as nail exchanges take place commonly in a surgery of this type.