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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 21 of 63

Device	Model / Reference	Registries	Class	Status
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 46cm	1311-046	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 45cm x 130°	1059-455	FDA UDI	Class II	Active
Antegrade Femoral Nail Case Right Case 2	9932	FDA UDI	Class I	Active
AOS HUMERAL NAIL 7mm x 30.0cm	S1171-300	FDA UDI	Class II	Unknown
AOS Ball Nose Guide Wire, 3.0mm x 520mm	0101-520	FDA UDI	Class I	Active
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 90mm	8042-090	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 44cm	S1309-044	FDA UDI	Class II	Unknown
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 105mm	1099-105	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø11mm x 30cm x 125°	1022-300	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 70mm	8059-070	FDA UDI	Class II	Active
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 85mm	8060-085	FDA UDI	Class II	Active
AOS RETROGRADE FEMORAL NAIL 12mm x 28cm	1342-028	FDA UDI	Class II	Active
TROCHANTERIC NAIL TRAY, LONG, Ø10mm x 125°	9962-000	FDA UDI	Class II	Active
Proximal Lateral Tibia Plate, Left, 3 Hole	3081-103	FDA UDI	Class II	Active
Partially Threaded Screw, 4.0mm x 34mm	8086-034	FDA UDI	Class II	Active
Ball Hex Driver, Cannulated	0406-200	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 135mm	S8059-135	FDA UDI	Class II	Unknown
Reamer Shaft Extension, Large Hudson	4012-100	FDA UDI	Class II	Active
AOS TIBIAL NAIL 13mm x 42.0cm	1113-420	FDA UDI	Class II	Active
AOS SMALL BONE REAMER Ø4.1 x 328mm	4020-041	FDA UDI	Class II	Active
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 55mm x 15mm	1411-055	FDA UDI	Class II	Active
MODULAR FLEXIBLE REAMER HEAD, Ø12.5mm	0234-125	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø11mm x 33cm x 125°	1023-330	FDA UDI	Class II	Active
AOS CANNULATED TAP 5.1mm	0281	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 30cm	S1319-030	FDA UDI	Class II	Unknown
AOS CANNULATED DRILL (LARGE HUDSON) 5.0mm	0290	FDA UDI	Class I	Active
T15 Cannulated Screwdriver, Self Retaining	5014-100	FDA UDI	Class II	Active
Slotted Mallet	0805	FDA UDI	Class I	Active
MONOBLOC REAMER 10.5mm	0231-105	FDA UDI	Class I	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 30mm	8065-030	FDA UDI	Class II	Active
AOS SOLID LOCKING LAG SCREW 10.5mm x 95mm	1094-095	FDA UDI	Class II	Active
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 55mm x 10mm	1410-055	FDA UDI	Class II	Active
Fast Threaded Guide Pin, 1.5mm	0120-150	FDA UDI	Class I	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 28mm	8014-280	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 95mm	8103-095	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 46mm	8001-046	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 30cm x 130°	S1123-300	FDA UDI	Class II	Unknown
CORTICAL BONE SCREW 3.5mm x 35mm	8110-035	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 6.5mm x 115mm	8020-115	FDA UDI	Class II	Active
AOS TARGET CORTICAL SCREW 5.0mm x 12.5mm	8008-125	FDA UDI	Class II	Active
Thread-In Sleeve, Small External Fixation System	0358	FDA UDI	Class I	Active
AOS CANCELLOUS SCREW 6.5mm x 100mm	8020-100	FDA UDI	Class II	Active
AOS Guide Pin, 2.8mm x 350mm	0112	FDA UDI	Class I	Active
Reduction Tool	0804-000	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 36cm	S1315-036	FDA UDI	Class II	Unknown
AOS RETROGRADE FEMORAL NAIL 12mm x 34cm	1342-034	FDA UDI	Class II	Active
AOS TIBIAL NAIL 9mm x 30.0cm	1109-300	FDA UDI	Class II	Active
CORTICAL SCREW 3.5mm x 32.5mm	8010-325	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 75mm	8103-075	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 11mm x 33cm x 130°	S1058-330	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.