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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 61 of 63

Device	Model / Reference	Registries	Class	Status
AOS TIBIAL NAIL 8mm x 33.0cm	S1108-330	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 60mm	8061-060	FDA UDI	Class II	Active
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 115mm	1092-115	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 38cm	S1316-038	FDA UDI	Class II	Unknown
Semi-Tubular Plate, 13-Hole	3060-013	FDA UDI	Class II	Active
Locking Bolt, Tibial Insertion Guide, Suprapatellar	1256-100	FDA UDI	Class II	Active
Fibonacci™ Proximal Posteromedial Tibia Plate, Left, 4 Hole	3085-004	FDA UDI	Class II	Active
ES™ RETROGRADE FEMORAL NAIL 11mm x 34cm	1391-034	FDA UDI	Class II	Active
Minimally Invasive Calcaneal Plate, Right, Medium	3077-040	FDA UDI	Class II	Active
AOS TIBIAL NAIL 13mm x 39.0cm	1113-390	FDA UDI	Class II	Active
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 140mm x 20mm	1416-140	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL 9mm x 17cm x 130°	S1034-170	FDA UDI	Class II	Unknown
AOS CANCELLOUS LOCKING SCREW 4.0mm x 24mm	8023-024	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 140mm	S8059-140	FDA UDI	Class II	Unknown
AOS TROCHANTERIC NAIL, RIGHT 11mm x 33cm x 130°	S1059-330	FDA UDI	Class II	Unknown
Lite Semi-Tubular Plate, 17-Hole	3060-917	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 34cm	S1308-034	FDA UDI	Class II	Unknown
AOS CAPTURED END CAP WITH POST 1mm	S1048-019	FDA UDI	Class II	Unknown
MODULAR FLEXIBLE REAMER HEAD, Ø11.0mm	0234-110	FDA UDI	Class II	Active
AOS TIBIAL NAIL 9mm x 36.0cm	S1109-360	FDA UDI	Class II	Unknown
Hook Tip Depth Gauge Locking / Non-Locking Screw	0523-100	FDA UDI	Class I	Active
Cannulated Curved Awl	0213	FDA UDI	Class I	Active
AOS DISTAL DRILL GUIDE 2.5mm	0307	FDA UDI	Class I	Active
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 80mm	1300-080	FDA UDI	Class II	Active
AOS ANTI-ROTATION SCREW 5.0mm x 50mm	8021-050	FDA UDI	Class II	Active
AOS SUPRACONDYLAR FEMORAL NAIL 12cm x18cm	1346-018	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 40cm	1313-040	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 30mm	8014-300	FDA UDI	Class II	Active
CANNULATED ENTRY REAMER, HUDSON 12.0mm	0228-100	FDA UDI	Class I	Active
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 110mm	1099-110	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 50mm	8080-050	FDA UDI	Class II	Active
Aos Anterior Clavicle Plate 9-Hole	3007-040	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 42cm x 130°	S1066-425	FDA UDI	Class II	Unknown
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 125mm	8042-125	FDA UDI	Class II	Active
AOS MODULAR NAIL 12.0mm x 36cm	1012-360	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL 10mm x 20cm x 135°	1042-200	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 30cm x 130°	1058-305	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 115mm	8041-115	FDA UDI	Class II	Active
AOS CORTICAL TAP, LARGE HUDSON 3.5mm	0286	FDA UDI	Class I	Active
Adjustable Stop	0211-100	FDA UDI	Class I	Active
AOS TIBIAL NAIL 9mm x 34.5cm	S1109-345	FDA UDI	Class II	Unknown
Straight Plate, 19-Hole	3061-019	FDA UDI	Class II	Active
AOS TIBIAL NAIL 8mm x 39.0cm	S1108-390	FDA UDI	Class II	Unknown
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 95mm	1192-095	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 65mm	8024-065	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 44cm	1309-044	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 47.5mm	S8022-047	FDA UDI	Class II	Unknown
AOS HUMERAL NAIL 9mm x 22.5cm	S1173-225	FDA UDI	Class II	Unknown
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 80mm	8100-080	FDA UDI	Class II	Active
Distal Hook Plate, Short, 3-Hole	3043-003	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.