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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 2 of 63

Device	Model / Reference	Registries	Class	Status
AOS CANCELLOUS SCREW 5.0mm x 27.5mm	S8022-027	FDA UDI	Class II	Unknown
AOS CORTICAL SCREW 3.5mm x 32.5mm	S8010-325	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 32cm	S1313-032	FDA UDI	Class II	Unknown
AOS END CAP, ANTEGRADE FEMORAL NAIL 10.0mm	S1322-010	FDA UDI	Class II	Unknown
AOS Hex Screw Driver 2.5mm	0432-200	FDA UDI	Class I	Active
AOS Cannulated Hex Driver, Small Hudson 5.0mm	0429-000	FDA UDI	Class I	Active
AOS CAPTURED BULLET TIP END CAP, TROCHANTERIC NAIL 1mm	S1047-019	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 34cm	1316-034	FDA UDI	Class II	Active
CALIBRATED DRILL, AO STYLE 4.0mm x 280mm	S0219-100	FDA UDI	Class I	Active
AOS LAG SCREW 10.5mm x 120mm	S1045-120	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 13mm x 36.0cm	1113-360	FDA UDI	Class II	Active
Fibonacci™ Proximal Lateral Tibia Plate, Right, 5 Hole	3082-005	FDA UDI	Class II	Active
Oblique T-Plate, Left, 3 x 5-Hole	3064-008	FDA UDI	Class II	Active
Cutting Tool, Galileo™ Explant	4003	FDA UDI	Class I	Active
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 100mm x 10mm	1414-100	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 55mm	8001-055	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, Ø10mm x 17cm x 130°	1040-170	FDA UDI	Class II	Active
Antegrade Femoral Nail Case Left Case 1	9929	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL 10mm x 17cm x 130°	S1040-170	FDA UDI	Class II	Unknown
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 16mm	8114-016	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 85mm	8081-085	FDA UDI	Class II	Active
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 120mm	8060-120	FDA UDI	Class II	Active
AOS TIBIAL NAIL 9mm x 33.0cm	1109-330	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 40cm	S1311-040	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 45cm x 130°	S1058-455	FDA UDI	Class II	Unknown
AOS CANNULATED BLOCKING SCREW 5.0mm x 35mm	8045-035	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 115mm	S8061-115	FDA UDI	Class II	Unknown
Screw Sheath-Short Humeral Nail	0601	FDA UDI	Class I	Active
Non-Locking Screw, 4.0mm x 42mm	8085-042	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW 4.0mm x 65mm	8023-065	FDA UDI	Class II	Active
AOS Cannulated Drill 5.0mm	0214	FDA UDI	Class I	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 105mm	S8065-105	FDA UDI	Class II	Unknown
Locking Wheel	1276	FDA UDI	Class I	Active
Aos Cannulated Lag Screw Tap, Large Hudson	0259	FDA UDI	Class I	Active
Distal Depth Gauge	0514-200	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 40mm	8059-040	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 70mm	S8060-070	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 8mm x 37.5cm	1108-375	FDA UDI	Class II	Active
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 110mm	8060-110	FDA UDI	Class II	Active
AOS ANTI-ROTATION SCREW 5.0mm x 70mm	S8021-070	FDA UDI	Class II	Unknown
Aos Multi-Pin Clamp Assembly	1158	FDA UDI	Class II	Active
Variable Angle Locking Screw, 2.7mm x 18mm	8087-018	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 115mm	S8001-115	FDA UDI	Class II	Unknown
Proximal Tibial Instrument Tray	9956-100	FDA UDI	Class II	Active
Capturing Rod, Galileo® Lag Screw	0455-100	FDA UDI	Class II	Active
CARBON FIBER ROD, Ø9.5mm x 250mm	1152-250	FDA UDI	Class II	Active
AOS RETROGRADE FEMORAL NAIL 11mm x 40cm	1341-040	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 90mm	8065-090	FDA UDI	Class II	Active
AOS RETROGRADE FEMORAL NAIL 12mm x 30cm	1342-030	FDA UDI	Class II	Active
Cortical Screw, 5.0mm x 80mm	8000-080	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.