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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 18 of 63

Device	Model / Reference	Registries	Class	Status
AOS TIBIAL NAIL 12mm x 33.0cm	S1112-330	FDA UDI	Class II	Unknown
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 75mm x 10mm	1414-075	FDA UDI	Class II	Active
MODULAR FLEXIBLE REAMER HEAD, Ø14.0mm	0234-140	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 80mm	8080-080	FDA UDI	Class II	Active
Locking Bolt Retrograde Femoral Nail	1284	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 48cm x 130°	S1066-485	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 33cm x 130°	1059-335	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 45mm	8110-045	FDA UDI	Class II	Active
AOS CORTICAL SCREW 3.5mm x 50.0mm	S8010-500	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 38cm	1309-038	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 40mm	S8022-040	FDA UDI	Class II	Unknown
AOS CANCELLOUS SCREW 5.0mm x 50mm	S8022-050	FDA UDI	Class II	Unknown
Variable Angle Locking Screw, 2.7mm x 28mm	8087-028	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 55mm	S8059-055	FDA UDI	Class II	Unknown
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 130mm	8041-130	FDA UDI	Class II	Active
AOS CALIBRATED DRILL, AO STYLE 2.5mm x 95mm	0253	FDA UDI	Class I	Active
Guide Wire Depth Gauge	0512-200	FDA UDI	Class II	Active
CORTICAL SCREW 3.5mm x 30.0mm	8010-300	FDA UDI	Class II	Active
AOS TIBIAL NAIL 13mm x 40.5cm	1113-405	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 10mm	8114-010	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 34mm	8024-034	FDA UDI	Class II	Active
ES™ RETROGRADE FEMORAL NAIL 13mm x 38cm	1393-038	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 36mm	8080-036	FDA UDI	Class II	Active
Double Round Guide Wire, 1.3mm x 400mm	0118-000	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 20mm	S8002-020	FDA UDI	Class II	Unknown
Variable Angle Locking Screw, 2.7mm x 22mm	8087-022	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 26mm	8024-026	FDA UDI	Class II	Active
AOS SOLID LOCKING LAG SCREW 10.5mm x 120mm	S1094-120	FDA UDI	Class II	Unknown
AOS LAG SCREW 10.5mm x 115mm	S1045-115	FDA UDI	Class II	Unknown
Non-Locking Screw, 2.7mm x 34mm	8083-034	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW 4.0mm x 38mm	8023-038	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 10mm	8014-100	FDA UDI	Class II	Active
Lite Semi-Tubular Plate, 5-Hole	3060-905	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 55.0mm	8002-055	FDA UDI	Class II	Active
Capturing Rod Nut, Galileo® Lag Screw	5046-100	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 85.0mm	8002-085	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 75mm	8080-075	FDA UDI	Class II	Active
AOS TIBIAL NAIL 11mm x 34.5cm	1111-345	FDA UDI	Class II	Active
Reduction Tool Tibial Nail	0838	FDA UDI	Class I	Active
Locking Bolt, Radiolucent Insertion Guide	1269-000	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 14mm	8110-014	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL 13mm x 20cm x 130°	S1037-200	FDA UDI	Class II	Unknown
Square Quick Connect Assembly	0834	FDA UDI	Class I	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 95mm	8100-095	FDA UDI	Class II	Active
AOS CORTICAL SCREW 2.7mm x 24mm	8036-024	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 22mm	8014-220	FDA UDI	Class II	Active
Anterolateral Distal Tibia Plate, Xl, 27-Hole, Right	3036-027	FDA UDI	Class II	Active
Galileo Screws Set	9964-000	FDA UDI	Class II	Active
Variable Angle Locking Screw, 2.7mm x 16mm	8087-016	FDA UDI	Class II	Active
Fibonacci™ Proximal Posteromedial Tibia Plate, Right, 8 Hole	3086-008	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.