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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 50 of 63

Device	Model / Reference	Registries	Class	Status
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 38cm	S1308-038	FDA UDI	Class II	Unknown
Impactor Pad Cannulated	0800-300	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 47.5mm	S8002-047	FDA UDI	Class II	Unknown
Lower Extremity Reamers Case	9918	FDA UDI	Class I	Active
AOS TIBIAL NAIL 10mm x 36.0cm	1110-360	FDA UDI	Class II	Active
ES™ RETROGRADE FEMORAL NAIL 11mm x 36cm	1391-036	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 33cm	1190-335	FDA UDI	Class II	Active
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 100mm x 25mm	1417-100	FDA UDI	Class II	Active
AOS Lag Screw Inserter	0403	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 42cm	S1317-042	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW 4.2mm x 70mm	S8002-070	FDA UDI	Class II	Unknown
Trochanteric Nail Tray, Base And Lid	9960-000	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 45mm	8042-045	FDA UDI	Class II	Active
Variable Angle Locking Screw, 2.7mm x 26mm	8087-026	FDA UDI	Class II	Active
AOS HUMERAL NAIL 9.0mm x 20cm	1173-200	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 90mm	8040-090	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 70mm	8024-070	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 2.7mm x 14mm	8030-014	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 48cm x 125°	1021-480	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 16mm	8012-160	FDA UDI	Class II	Active
Radiolucent Targeting Arm, 130° Trochanteric Nail	1268-100	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 25.0mm	8002-025	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 90mm	8100-090	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 48mm	8081-048	FDA UDI	Class II	Active
AOS TIBIAL NAIL 12mm x 39.0cm	1112-390	FDA UDI	Class II	Active
AOS LAG SCREW 10.5mm x 125mm	S1045-125	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 38cm	1312-038	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 42cm x 130°	1123-420	FDA UDI	Class II	Active
Aos Mid-Shaft Superior Clavicle Plate Medium, Left	3005-040	FDA UDI	Class II	Active
Aos Screw Sheath	0316-100	FDA UDI	Class I	Active
CORTICAL BONE SCREW 3.5mm x 60mm	8110-060	FDA UDI	Class II	Active
Lite Semi-Tubular Plate, 7-Hole	3060-907	FDA UDI	Class II	Active
AOS TIBIAL NAIL 10mm x 39.0cm	1110-390	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 45cm x 130°	1050-450	FDA UDI	Class II	Active
MONOBLOC REAMER 7.5mm	0231-075	FDA UDI	Class I	Active
Variable Angle Locking Screw, 3.5mm x 65mm	8088-065	FDA UDI	Class II	Active
Retrograde Femoral Nail Case 12mm-13mm	9928	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 30cm x 125°	1121-305	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 33cm x 130°	1066-335	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 56mm	8028-056	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 34cm	S1315-034	FDA UDI	Class II	Unknown
AOS TROCHANTERIC NAIL, LEFT 11mm x 42cm x 125°	S1022-420	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 65mm	S8059-065	FDA UDI	Class II	Unknown
HEX DRIVER, SHORT, AO STYLE 2.5 mm	5016	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 48cm x 130°	1123-485	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 44cm	S1314-044	FDA UDI	Class II	Unknown
Reduction Forceps, Curved, Pointed, Long Ratchet	0901-100	FDA UDI	Class I	Active
Fibonacci Lower Extremity Plates Tray	9939-000	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 60.0mm	8002-060	FDA UDI	Class II	Active
GALILEO® LAG SCREW, LEFT, 10.5mm x 110mm	1199-110	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.