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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 5 of 63

Device	Model / Reference	Registries	Class	Status
Bending Template, Minimally Invasive Calcaneus Plate, Small	0549-020	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 34mm	8080-034	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 39cm x 125°	1022-390	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 42cm	1309-042	FDA UDI	Class II	Active
Non-Locking Screw, 2.4mm x 22mm	8082-022	FDA UDI	Class II	Active
Straight Plate, 15-Hole	3061-015	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 12.5mm x 33cm x 130°	1122-330	FDA UDI	Class II	Active
Insertion Knob Adaptor, Distal Targeting Tibial Nail	1265	FDA UDI	Class I	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 36mm	8114-036	FDA UDI	Class II	Active
AOS 2.6mm Solid Reamer	4021	FDA UDI	Class II	Active
GALILEO® LAG SCREW, LEFT, 10.5mm x 115mm	1199-115	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 11mm x 30cm x 130°	S1059-300	FDA UDI	Class II	Unknown
Ratcheting Small Axial Handle, Ao Quick Connect, Cannulated	5026-100	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 18mm	8114-018	FDA UDI	Class II	Active
Non-Locking Screw, 2.4mm x 36mm	8082-036	FDA UDI	Class II	Active
TIBIAL NAIL Case Assembly	9904-001	FDA UDI	Class I	Active
AOS TIBIAL NAIL 12mm x 37.5cm	S1112-375	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 13mm x 33.0cm	1113-330	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 12.5mm x 33cm x 130°	S1122-330	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 28cm	1310-028	FDA UDI	Class II	Active
AOS TIBIAL NAIL 13mm x 28.5cm	1113-285	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 90mm	S8065-090	FDA UDI	Class II	Unknown
Easyout Extractor Tibial Nail	0812	FDA UDI	Class I	Active
AOS TIBIAL NAIL 11mm x 37.5cm	S1111-375	FDA UDI	Class II	Unknown
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 80mm	8042-080	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 65.0mm	8022-065	FDA UDI	Class II	Active
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 110mm	1300-110	FDA UDI	Class II	Active
Ball Hex Driver	0406-100	FDA UDI	Class I	Active
Lateral Distal Fibula Plate, Xs, 10-Hole, Left	3051-010	FDA UDI	Class II	Active
Semi-Tubular Plate, 17-Hole	3060-017	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 35mm	S8060-035	FDA UDI	Class II	Unknown
AOS LAG SCREW 10.5mm x 80mm	S1045-080	FDA UDI	Class II	Unknown
Variable Angle Locking Screw, 3.5mm x 42mm	8088-042	FDA UDI	Class II	Active
Aos Proximal Humeral Plate 5 Hole	3012-005	FDA UDI	Class II	Active
Trochanteric Nail Set 4	9979-000	FDA UDI	Class II	Active
Insertion Guide, Low Profile Tibial Nail	1235-100	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 40mm	S8059-040	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 42cm	S1312-042	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 140mm	8061-140	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 6.5mm x 60mm	8020-060	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 85mm	8001-085	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 75mm	S8065-075	FDA UDI	Class II	Unknown
AOS TROCHANTERIC NAIL, LEFT 11mm x 36cm x 130°	1058-360	FDA UDI	Class II	Active
AOS END CAP, TIBIAL NAIL 5mm	S1115-050	FDA UDI	Class II	Unknown
T15 Cannulated Driver	5014-000	FDA UDI	Class I	Active
CORTICAL BONE SCREW 3.5mm x 10mm	8110-010	FDA UDI	Class II	Active
AOS Calibrated Drill, AO Style, 2.5mm x 95mm	0237-100	FDA UDI	Class I	Active
Variable Angle Locking Screw, 3.5mm x 36mm	8088-036	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 8mm	8014-080	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 40mm	8110-040	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.