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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 45 of 63

Device	Model / Reference	Registries	Class	Status
AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 110mm	1335-110	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 50mm	8100-050	FDA UDI	Class II	Active
AOS CANCELLOUS LAG SCREW 4.0mm x 38mm	8032-038	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 75mm	S8001-075	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 115mm	S8060-115	FDA UDI	Class II	Unknown
Lateral Distal Fibula Plate, Xs, 10-Hole, Right	3052-010	FDA UDI	Class II	Active
Insertion Guide, Extended Humeral Nail	1230-100	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 39cm x 130°	1122-395	FDA UDI	Class II	Active
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 58mm	8124-058	FDA UDI	Class II	Active
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 12mm	8031-012	FDA UDI	Class II	Active
Easyout Extractor Tibial Nail	0812-100	FDA UDI	Class I	Active
AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 50mm	1160-180	FDA UDI	Class II	Active
CARBON FIBER ROD, Ø5.0mm x 150mm	1181-150	FDA UDI	Class II	Active
Galileo® Lag Screw Inserter	5030-000	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 30mm	8100-030	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 37.5mm	8002-037	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 60mm	8065-060	FDA UDI	Class II	Active
AOS TIBIAL NAIL 11mm x 39.0cm	1111-390	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 58mm	8028-058	FDA UDI	Class II	Active
Ball Hex Driver, Cannulated	0494	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 110mm	8059-110	FDA UDI	Class II	Active
AOS GALILEO™ LAG SCREW 10.5mm x 100mm	S1099-100	FDA UDI	Class II	Unknown
AOS END CAP, ANTEGRADE FEMORAL NAIL 5.0mm	1322-005	FDA UDI	Class II	Active
AOS CANNULATED BLOCKING SCREW 5.0mm x 80mm	S8045-080	FDA UDI	Class II	Unknown
AOS Lag Screw Capturing Rod	0405-100	FDA UDI	Class I	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 14mm	8114-014	FDA UDI	Class II	Active
Radiolucent Targeting Arm, Trochanteric Nail 125°	1267	FDA UDI	Class I	Active
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 140mm x 25mm	1417-140	FDA UDI	Class II	Active
AOS Galileo Lag Screw Inserter	0454	FDA UDI	Class I	Active
5.0mm HEX DRIVER, AO STYLE	5001-100	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 28cm	S1310-028	FDA UDI	Class II	Unknown
AOS END CAP, MODULAR NAIL 10.0mm	1015-100	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 42cm x 125°	S1022-425	FDA UDI	Class II	Unknown
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 45cm x 125°	1021-455	FDA UDI	Class II	Active
Trochanteric Nail Set 1	9976-000	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 38cm	S1313-038	FDA UDI	Class II	Unknown
OBTURATOR, Ø5.0mm A/R DRILL GUIDE	0620-000	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 11mm x 42cm x 130°	1058-420	FDA UDI	Class II	Active
Easyout Extractor, Galileo™ Lag Screw	0833	FDA UDI	Class I	Active
Aos Anterior Clavicle Plate 7-Hole	3007-020	FDA UDI	Class II	Active
Bone Hook	0820	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL 12mm x 20cm x 125°	S1032-200	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 36cm	1190-365	FDA UDI	Class II	Active
AOS HUMERAL NAIL 8.0mm x 30cm	1172-300	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 32mm	8103-032	FDA UDI	Class II	Active
Proximal Lateral Tibia Plate, Right, 5 Hole	3082-105	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 48cm x 130°	1050-480	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 22mm	8100-022	FDA UDI	Class II	Active
Cannulated Hudson Adaptor Lg-Male, Sm-Female	0443-100	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 40cm	1311-040	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.