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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 49 of 63

Device	Model / Reference	Registries	Class	Status
AOS CANCELLOUS SCREW 5.0mm x 32.5mm	S8022-032	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 12mm x 34.5cm	1112-345	FDA UDI	Class II	Active
AOS MODULAR NAIL 13.0mm x 30cm	1013-300	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 39cm x 125°	1121-395	FDA UDI	Class II	Active
AOS TIBIAL NAIL 8mm x 34.5cm	1108-345	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 38cm	S1309-038	FDA UDI	Class II	Unknown
Locking Bolt, Insertion Guide Tibial Nail	1236	FDA UDI	Class I	Active
AOS Calibrated Drill, 4.0mm x 165mm	0225	FDA UDI	Class I	Active
CORTICAL TAP 3.5mm	0226	FDA UDI	Class I	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 48cm x 125°	1020-480	FDA UDI	Class II	Active
Locking Bolt, Radiolucent Insertion Guide Trochanteric Nail	1225-200	FDA UDI	Class I	Active
AOS CANNULATED BLOCKING SCREW 5.0mm x 75mm	S8045-075	FDA UDI	Class II	Unknown
SNAP-IN DRILL GUIDE, Ø2.8mm	0352-100	FDA UDI	Class I	Active
AOS Cannulated Straight Awl	0218	FDA UDI	Class I	Active
MODULAR FLEXIBLE REAMER HEAD, Ø16.5mm	0234-165	FDA UDI	Class II	Active
Screw Sheath	0601-100	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 40mm	S8061-040	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 46cm	S1310-046	FDA UDI	Class II	Unknown
MONOBLOC REAMER 10.0mm	0231-100	FDA UDI	Class I	Active
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 140mm x 15mm	1411-1401	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 60mm	8042-060	FDA UDI	Class II	Active
PIN GUIDE, Ø3.2mm SOFT TISSUE PROTECTOR	0304-100	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 50mm	8040-050	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 36mm	8110-036	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 10mm x 33cm x 130°	1067-335	FDA UDI	Class II	Active
AOS CORTICAL SCREW 3.5mm x 37.5mm	S8010-375	FDA UDI	Class II	Unknown
Non-Locking Screw, 3.5mm x 14mm	8084-014	FDA UDI	Class II	Active
Variable Angle Locking Screw, 2.7mm x 10mm	8087-010	FDA UDI	Class II	Active
AOS CORTICAL SCREW 2.7mm x 12mm	8036-012	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 30cm	1317-030	FDA UDI	Class II	Active
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 120mm	1045-120	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 10mm x 33cm x 130°	S1051-330	FDA UDI	Class II	Unknown
Semi-Tubular Plate, 3-Hole	3060-003	FDA UDI	Class II	Active
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 125mm	1099-125	FDA UDI	Class II	Active
CALIBRATED DRILL, AO STYLE, Ø2.8mm x 95mm	0237-200	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 33cm x 130°	S1068-335	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 11mm x 27.0cm	S1111-270	FDA UDI	Class II	Unknown
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 33cm x 125°	1021-335	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 34cm	S1310-034	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 39cm x 130°	S1066-395	FDA UDI	Class II	Unknown
AOS RETROGRADE FEMORAL NAIL 13mm x 34cm	1343-034	FDA UDI	Class II	Active
Anterolateral Distal Tibia Plate, Xl, 27-Hole, Left	3035-027	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 33cm x 125°	1021-330	FDA UDI	Class II	Active
Lite Semi-Tubular Plate, 3-Hole	3060-903	FDA UDI	Class II	Active
Easy Out Extractor, Galileo™ Explant	0850	FDA UDI	Class I	Active
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 125mm	1092-125	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 42cm x 125°	1022-420	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 30cm	1310-030	FDA UDI	Class II	Active
AOS TIBIAL NAIL 13mm x 30.0cm	1113-300	FDA UDI	Class II	Active
Lag Screw Sheath	0603-200	FDA UDI	Class I	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.