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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 28 of 63

Device	Model / Reference	Registries	Class	Status
Clavicle Nail System Bottom Shelf	9934	FDA UDI	Class I	Active
DRILL, AO STYLE, 4.0mm x 149mm	0210-400	FDA UDI	Class I	Active
Upper Extremity Reamer Set	9923	FDA UDI	Class I	Active
AOS MODULAR NAIL 11.0mm x 42cm	1011-420	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 44cm	S1315-044	FDA UDI	Class II	Unknown
Variable Angle Locking Screw, 3.5mm x 40mm	8088-040	FDA UDI	Class II	Active
REAMER HEAD 8.0mm	0223-080	FDA UDI	Class I	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 100mm	8065-100	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 45mm	8014-450	FDA UDI	Class II	Active
AOS Reamer Head, 11.5mm	0204-115	FDA UDI	Class I	Active
AOS Reamer Head, 9.0mm	0204-090	FDA UDI	Class I	Active
Proximal Screw Depth Gauge	0522-100	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL, RIGHT 11mm x 33cm x 130°	1059-330	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 36cm	S1312-036	FDA UDI	Class II	Unknown
MODULAR FLEXIBLE REAMER HEAD, Ø16.0mm	0234-160	FDA UDI	Class II	Active
Non-Locking Screw, 4.0mm x 65mm	8085-065	FDA UDI	Class II	Active
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 100mm	1300-100	FDA UDI	Class II	Active
T10 Screwdriver, Short	5025	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 36cm	S1314-036	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 33cm	1191-335	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 36cm	1313-036	FDA UDI	Class II	Active
Proximal Lateral Tibia Plate, Left, 11 Hole	3081-111	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 85mm	8103-085	FDA UDI	Class II	Active
Medial Pilon Plate, Xxl, 29-Hole, Right	3032-029	FDA UDI	Class II	Active
AOS RETROGRADE FEMORAL NAIL 10mm x 42cm	1340-042	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 44mm	S8001-044	FDA UDI	Class II	Unknown
Aos Mid-Shaft Superior Clavicle Plate Medium, Right	3006-040	FDA UDI	Class II	Active
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 42cm x 125°	1021-425	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 140mm	S8061-140	FDA UDI	Class II	Unknown
Ø2.8mm DRILL GUIDE, NON-LOCKING/LOCKING PHP	0318-200	FDA UDI	Class II	Active
Galileo Extraction Tool, Capturing Rod Nut	0858-200	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 11mm x 36cm x 125°	S1023-360	FDA UDI	Class II	Unknown
Proximal Tibial Screw Tray	9957-000	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 44mm	8081-044	FDA UDI	Class II	Active
POWER TORQUE LIMITING ADAPTER AO STYLE, 1.35 Nm	5005	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 34cm	1309-034	FDA UDI	Class II	Active
Soft Tissue Protector	0649-000	FDA UDI	Class II	Active
Silicone Palm Handle, Pull Back Ao Connection	5035-100	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 80mm	S8022-080	FDA UDI	Class II	Unknown
Locking Bolt, Tibial Insertion Guide, Extended	1256	FDA UDI	Class I	Active
ES™ RETROGRADE FEMORAL NAIL 12mm x 40cm	1392-040	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 10mm x 33cm x 130°	S1067-335	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 28cm	S1315-028	FDA UDI	Class II	Unknown
AOS CANNULATED BLOCKING SCREW 5.0mm x 45mm	S8045-045	FDA UDI	Class II	Unknown
AOS Drill, AO Style, 2.9mm x 100mm	0224	FDA UDI	Class II	Active
Straight Plate, 5-Hole	3061-005	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 34mm	8001-034	FDA UDI	Class II	Active
AOS CORTICAL SCREW 5.0mm x 120mm	8000-120	FDA UDI	Class II	Active
7.0mm Cannulated Screw System Case	9913	FDA UDI	Class I	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 100mm	8061-100	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.