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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 27 of 63

Device	Model / Reference	Registries	Class	Status
Non-Locking Screw, 3.5mm x 22mm	8084-022	FDA UDI	Class II	Active
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 100mm	1099-100	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 22mm	8024-022	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 60mm	8081-060	FDA UDI	Class II	Active
AOS CORTICAL SCREW 2.7mm x 28mm	8036-028	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 30cm x 130°	1068-305	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 48cm	1308-048	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 33cm x 125°	1022-330	FDA UDI	Class II	Active
AOS Screw Gripper	0413	FDA UDI	Class I	Active
AOS RETROGRADE FEMORAL NAIL 12mm x 40cm	1342-040	FDA UDI	Class II	Active
Insert Standard	1005	FDA UDI	Class II	Active
AOS Reamer Head, 10.0mm	0204-100	FDA UDI	Class I	Active
Lateral Distal Fibula Plate, Xxl, 21-Hole, Left	3051-021	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 95mm	8041-095	FDA UDI	Class II	Active
AOS Reamer Head, 12.0mm	0204-120	FDA UDI	Class I	Active
AOS Locking Knob Distal Targeting, Tibial Nail	0437	FDA UDI	Class I	Active
Cannulated Capturing Rod	0484	FDA UDI	Class I	Unknown
AOS TROCHANTERIC NAIL, RIGHT 11mm x 42cm x 130°	S1059-420	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 11mm x 31.5cm	S1111-315	FDA UDI	Class II	Unknown
AOS PIN GUIDE 3.2mm	0303-200	FDA UDI	Class I	Active
AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 5mm	S1047-059	FDA UDI	Class II	Unknown
AOS Reamer Head, 16.0mm	0204-160	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 40cm	1308-040	FDA UDI	Class II	Active
AOS Guide Pin, 3.2mm x 381mm	0100-381	FDA UDI	Class I	Active
CALIBRATED DRILL, AO STYLE 2.5mm x 160mm	S0217-100	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL, RIGHT 10mm x 45cm x 130°	S1051-450	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 40cm	S1312-040	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 9mm x 27.0cm	S1109-270	FDA UDI	Class II	Unknown
AOS CANNULATED BLOCKING SCREW 5.0mm x 50mm	8045-050	FDA UDI	Class II	Active
AOS CANNULATED HIP SCREW DRILL, LARGE HUDSON 10.3mm	0258	FDA UDI	Class I	Active
AOS PROXIMAL DRILL GUIDE 3.5mm	0309	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 30cm x 125°	1120-305	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 30cm	S1317-030	FDA UDI	Class II	Unknown
LOCKING GUIDE, DISTAL TARGETING 9mm Tibial Nail	1264-009	FDA UDI	Class I	Active
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 140mm x 15mm	1415-140	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 50mm	S8059-050	FDA UDI	Class II	Unknown
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 12mm	8103-012	FDA UDI	Class II	Active
Galileo Removal Tool	0856-100	FDA UDI	Class II	Active
Easy Out Extractor, Clavicle Im Device	0849	FDA UDI	Class I	Active
AOS Cannulated Lag Screw Drill, 10.3mm	0206-300	FDA UDI	Class I	Active
CORTICAL LOCKING SCREW 3.5mm x 14mm	8012-140	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 24mm	8080-024	FDA UDI	Class II	Active
LOCKING GUIDE, DISTAL TARGETING 10mm Tibial Nail	1264-010	FDA UDI	Class I	Active
AOS CALIBRATED DRILL (AO STYLE) 5.5mm	0288-100	FDA UDI	Class I	Active
18cm EXTENSION, RETROGRADE TARGETING GUIDE	1282	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 36cm x 130°	1059-365	FDA UDI	Class II	Active
REAMER HEAD 6.0mm	0223-060	FDA UDI	Class I	Active
AOS CANCELLOUS SCREW 5.0mm x 95.0mm	8022-095	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 130mm	S8061-130	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 33cm x 125°	S1022-335	FDA UDI	Class II	Unknown

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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.