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ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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: —
Email: [email protected]
Phone: (310) 533-9966
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117858154

Catalogue (3113)

Page 39 of 63

Device	Model / Reference	Registries	Class	Status
AOS TIBIAL NAIL 10mm x 33.0cm	1110-330	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 6.5mm x 120mm	8020-120	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 28cm	S1319-028	FDA UDI	Class II	Unknown
AOS Guide Pin, 2.4mm x 450mm	0113	FDA UDI	Class I	Active
Alignment Guide Proximal Humeral Plate	1250-200	FDA UDI	Class I	Active
Partially Threaded Screw, 4.0mm x 48mm	8086-048	FDA UDI	Class II	Active
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 70mm	1045-070	FDA UDI	Class II	Active
Non-Locking Screw, 4.0mm x 55mm	8085-055	FDA UDI	Class II	Active
AOS CORTICAL SCREW 2.7mm x 22mm	8036-022	FDA UDI	Class II	Active
Reduction Tool, Tibial Nail	0838-100	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 32mm	8080-032	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 10mm x 45cm x 130°	1067-455	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 50mm	8081-050	FDA UDI	Class II	Active
AOS Drill, AO Style, 4.0mm x 165mm	0210-300	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL 12mm x 17cm x 125°	1032-170	FDA UDI	Class II	Active
Aos Clavicle Plate, Midshaft Superior 6 Hole Medium, Left	3019-040	FDA UDI	Class II	Active
AOS CORTICAL SCREW 5.0mm x 115mm	8000-115	FDA UDI	Class II	Active
Pin Guide, Soft Tissue Protector, Galileo™ Explant	0345	FDA UDI	Class I	Active
AOS TIBIAL NAIL 10mm x 33.0cm	S1110-330	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 10mm x 39cm x 130°	S1067-395	FDA UDI	Class II	Unknown
AOS DRILL GUIDE, MULTI-PIN CLAMP 4.0mm	0326	FDA UDI	Class I	Active
AOS TIBIAL NAIL 9mm x 34.5cm	1109-345	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 39cm x 130°	1058-395	FDA UDI	Class II	Active
Hex Driver	0407	FDA UDI	Class I	Active
MONOBLOC REAMER 6.5mm	0231-065	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 46cm	S1316-046	FDA UDI	Class II	Unknown
AOS Calibrated Drill, Long 2.5mm x 130mm	0250	FDA UDI	Class I	Active
AOS MODULAR NAIL 11.0mm x 36cm	1011-360	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 10mm x 33cm x 130°	S1050-330	FDA UDI	Class II	Unknown
AOS CORTICAL LOCKING SCREW 3.5mm x 26mm	8014-260	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 90mm	8103-090	FDA UDI	Class II	Active
AOS RETROGRADE FEMORAL NAIL 13mm x 44cm	1343-044	FDA UDI	Class II	Active
MONOBLOC REAMER, HUDSON 8.0mm	0235-080	FDA UDI	Class I	Unknown
ES™ RETROGRADE FEMORAL NAIL 13mm x 32cm	1393-032	FDA UDI	Class II	Active
AOS HUMERAL NAIL 8.0mm x 25cm	1172-250	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 40mm	8014-400	FDA UDI	Class II	Active
AOS CANNULATED BLOCKING SCREW 5.0mm x 80mm	8045-080	FDA UDI	Class II	Active
AOS End Cap Gripper	0415	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 95mm	8001-095	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL 13mm x 17cm x 125°	1033-170	FDA UDI	Class II	Active
Proximal Lateral Tibia Plate, Right, 2 Hole	3082-102	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 30cm	1311-030	FDA UDI	Class II	Active
3.5mm Calibrated Drill	4025	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 100mm	8001-100	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 105mm	8041-105	FDA UDI	Class II	Active
AOS TIBIAL NAIL 11mm x 33.0cm	1111-330	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 48cm x 125°	1022-480	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 65mm	8040-065	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 24mm	8012-240	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 34cm	1319-034	FDA UDI	Class II	Active

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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.

Date	Recall No.	Class	Status	Reason
Jan 14, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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, 2010	Z-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.