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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 4 of 63

Device	Model / Reference	Registries	Class	Status
AOS LAG SCREW 10.5mm x 65mm	S1045-065	FDA UDI	Class II	Unknown
CORTICAL SCREW 3.5mm x 16.0mm	8010-160	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 32cm	S1311-032	FDA UDI	Class II	Unknown
MODULAR FLEXIBLE REAMER HEAD, Ø9.5mm	0234-095	FDA UDI	Class II	Active
CORTICAL SCREW 3.5mm x 40.0mm	8010-400	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 100mm	8042-100	FDA UDI	Class II	Active
AOS MODULAR NAIL 10.0mm x 38cm	1010-380	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 11mm x 30cm x 125°	S1022-300	FDA UDI	Class II	Unknown
AOS Guide Pin, Trocar Tip, 3.2mm x 381mm	0110-381	FDA UDI	Class I	Active
Cannulated Curved Awl, T-Handle	0256-200	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 50mm	8014-500	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 28cm	1314-028	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 10mm x 45cm x 130°	1051-450	FDA UDI	Class II	Active
AOS TIBIAL NAIL 11mm x 27.0cm	1111-270	FDA UDI	Class II	Active
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 60mm	1045-060	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 22mm	8114-022	FDA UDI	Class II	Active
Partially Threaded Screw, 4.0mm x 20mm	8086-020	FDA UDI	Class II	Active
Capturing Rod Wrench	5011	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 20mm	S8001-020	FDA UDI	Class II	Unknown
T10 Screwdriver, Self Retaining	5015-300	FDA UDI	Class II	Active
CORTICAL SCREW 3.5mm x 32.0mm	8010-320	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 48cm	1315-048	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 30mm	S8059-030	FDA UDI	Class II	Unknown
CALIBRATED DRILL, AO STYLE, 2.5mm x 160mm	0217-200	FDA UDI	Class I	Active
HEX SCREW DRIVER, LARGE HUDSON 2.5mm	5003	FDA UDI	Class I	Active
AOS CORTICAL SCREW 5.0mm x 70mm	8000-070	FDA UDI	Class II	Active
AOS TIBIAL NAIL 12mm x 31.5cm	S1112-315	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 45mm	8065-045	FDA UDI	Class II	Active
Medial Pilon Plate, Xxl, 29-Hole, Left	3031-029	FDA UDI	Class II	Active
AOS SOLID LOCKING LAG SCREW 10.5mm x 110mm	1094-110	FDA UDI	Class II	Active
AOS CALIBRATED STEP DRILL (AO STYLE) 4.8/6.0mm	0289	FDA UDI	Class I	Active
AOS ANTI-ROTATION SCREW 5.0mm x 75mm	S8021-075	FDA UDI	Class II	Unknown
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 85mm	1192-085	FDA UDI	Class II	Active
Non-Locking Screw, 3.5mm x 70mm	8084-070	FDA UDI	Class II	Active
Variable Angle Locking Screw, 3.5mm x 12mm	8088-012	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm	8059-075	FDA UDI	Class II	Active
AOS HUMERAL NAIL 9.0mm x 32.5cm	1173-325	FDA UDI	Class II	Active
T-Plate, 2x 5-Hole	3062-007	FDA UDI	Class II	Active
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 34mm	8031-034	FDA UDI	Class II	Active
AOS Ball Nose Guide Wire, 3.0mm x 760mm	0101-760	FDA UDI	Class I	Active
Variable Angle Locking Screw, 3.5mm x 50mm	8088-050	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 16mm	8110-016	FDA UDI	Class II	Active
AOS CORTICAL SCREW 3.5mm x 22.5mm	S8010-225	FDA UDI	Class II	Unknown
ES™ RETROGRADE FEMORAL NAIL 10mm x 36cm	1390-036	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 12.5mm x 39cm x 130°	1122-390	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 39cm x 125°	1020-390	FDA UDI	Class II	Active
Screw Sheath	0628	FDA UDI	Class I	Active
Aos Lateral Superior Clavicle Plate Straight, Right	3004-060	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 26mm	8001-026	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 14mm	8014-140	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.