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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 3 of 63

Device	Model / Reference	Registries	Class	Status
ES™ RETROGRADE FEMORAL NAIL 10mm x 34cm	1390-034	FDA UDI	Class II	Active
Partially Threaded Screw, 4.0mm x 46mm	8086-046	FDA UDI	Class II	Active
AOS TIBIAL NAIL 9mm x 36.0cm	1109-360	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 11mm x 30cm x 130°	1059-300	FDA UDI	Class II	Active
AOS LOCKING END CAP, ANTEGRADE FEMORAL NAIL 0mm	S1323	FDA UDI	Class II	Unknown
Variable Angle Locking Screw, 3.5mm x 55mm	8088-055	FDA UDI	Class II	Active
VARIABLE ANGLE LOCKING SCREW, 3.5mm x 95mm	8088-095	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 25.0mm	8022-025	FDA UDI	Class II	Active
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 90mm	1192-090	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 80mm	8040-080	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 39cm x 130°	1123-395	FDA UDI	Class II	Active
AOS LAG SCREW 10.5mm x 100mm	S1045-100	FDA UDI	Class II	Unknown
Hook Plate Drill Guide	0347	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 45mm	S8002-045	FDA UDI	Class II	Unknown
Square Quick Connect	0485	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL 10mm x 20cm x 125°	S1030-200	FDA UDI	Class II	Unknown
AOS Ratcheting Cannulated Screw Driver Handle Small Hudson	0431	FDA UDI	Class I	Active
Screw Capturing Rod	0422	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 42cm	S1310-042	FDA UDI	Class II	Unknown
AOS TROCHANTERIC NAIL, RIGHT 10mm x 36cm x 130°	1051-360	FDA UDI	Class II	Active
Semi-Tubular Plate, 7-Hole	3060-007	FDA UDI	Class II	Active
Aos 95° Proximal Humeral Plate 3 Hole	3016-003	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 39cm x 125°	1021-390	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 11mm x 36cm x 130°	S1058-360	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 125mm	8065-125	FDA UDI	Class II	Active
Capturing Rod, Galileo® Lag Screw	5033-100	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 36mm	8024-036	FDA UDI	Class II	Active
AOS TIBIAL NAIL 8mm x 27.0cm	S1108-270	FDA UDI	Class II	Unknown
Soft Tissue Protector	0655	FDA UDI	Class I	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 40mm	8103-040	FDA UDI	Class II	Active
Minimally Invasive Calcaneal Plate, Left, Extra Small	3076-010	FDA UDI	Class II	Active
CARBON FIBER ROD, Ø5.0mm x 200mm	1181-200	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 80mm	S8059-080	FDA UDI	Class II	Unknown
Aos Nut	1425	FDA UDI	Class II	Active
AOS TIBIAL NAIL 11mm x 31.5cm	1111-315	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, Ø10mm x 20cm x 130°	1040-200	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 6.5mm x 110mm	8020-110	FDA UDI	Class II	Active
AOS CALIBRATED CANCELLOUS TAP 6.0mm	0271	FDA UDI	Class I	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 85mm	S8061-085	FDA UDI	Class II	Unknown
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 145mm	8041-145	FDA UDI	Class II	Active
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 14mm	8031-014	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 46cm	S1315-046	FDA UDI	Class II	Unknown
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 42cm x 130°	1050-420	FDA UDI	Class II	Active
Wrench 3/4"-1/2"	0813	FDA UDI	Class I	Active
AOS DISTAL TARGETING DRILL GUIDE 4.0mm	0305	FDA UDI	Class I	Active
Non-Locking Screw, 4.0mm x 80mm	8085-080	FDA UDI	Class II	Active
Variable Angle Locking Screw, 3.5mm x 18mm	8088-018	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 100mm	8059-100	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 135mm	8042-135	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 48cm x 130°	S1069-485	FDA UDI	Class II	Unknown

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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.