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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 6 of 63

Device	Model / Reference	Registries	Class	Status
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 34cm	S1314-034	FDA UDI	Class II	Unknown
AOS CORTICAL SCREW 5.0mm x 65mm	8000-065	FDA UDI	Class II	Active
Alignment Guide Locking Bolt Proximal Humeral Plate	1251-100	FDA UDI	Class I	Active
AOS Reamer Head, 8.5mm	0204-085	FDA UDI	Class I	Active
Aos Lateral Superior Clavicle Plate Curved, Left	3003-020	FDA UDI	Class II	Active
Non-Locking Screw, 4.0mm x 26mm	8085-026	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 34cm	S1309-034	FDA UDI	Class II	Unknown
Straight Plate, 7-Hole	3061-007	FDA UDI	Class II	Active
AOS MODULAR NAIL 9.0mm x 44cm	1009-440	FDA UDI	Class II	Active
Non-Locking Screw, 4.0mm x 36mm	8085-036	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 80mm	S8065-080	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 35mm	8059-035	FDA UDI	Class II	Active
Impactor Pad Tibial Nail	0810	FDA UDI	Class I	Active
Screw Sheath	0624	FDA UDI	Class I	Active
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 32mm	8028-032	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 11mm x 39cm x 125°	S1023-390	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW 5.0mm x 42mm	S8001-042	FDA UDI	Class II	Unknown
AOS CANCELLOUS LAG SCREW 4.0mm x 20mm	8032-020	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 32mm	8100-032	FDA UDI	Class II	Active
AOS DEPTH LIMITING DRILL, AO STYLE 2.5mm	0274	FDA UDI	Class I	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 140mm	8041-140	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 38mm	8100-038	FDA UDI	Class II	Active
Non-Locking Screw, 4.0mm x 70mm	8085-070	FDA UDI	Class II	Active
Flexible Reamer Shaft, Nitinol, Hudson	0233-000	FDA UDI	Class II	Active
CARBON FIBER ROD, Ø5.0mm x 50mm	1181-050	FDA UDI	Class II	Active
Proximal Lateral Tibia Plate, Left, 5 Hole	3081-105	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 115mm	8059-115	FDA UDI	Class II	Active
ES™ TROCHANTERIC NAIL, LEFT, Ø11mm x 42cm x 125°	1022-425	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 75mm	S8059-075	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 48cm x 130°	1059-485	FDA UDI	Class II	Active
AOS CORTICAL LOCKING SCREW 3.5mm x 60mm	8014-600	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 28cm	1316-028	FDA UDI	Class II	Active
AOS RETROGRADE FEMORAL NAIL 13mm x 38cm	1343-038	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 150mm	8040-150	FDA UDI	Class II	Active
Non-Locking Screw, 2.4mm x 32mm	8082-032	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 32cm	1318-032	FDA UDI	Class II	Active
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 48cm x 125°	1021-485	FDA UDI	Class II	Active
AOS 13.5mm CANNULATED ENTRY REAMER LARGE HUDSON	0266	FDA UDI	Class I	Active
AOS CORTICAL SCREW 3.5mm x 14.0mm	S8010-140	FDA UDI	Class II	Unknown
Alignment Guide Proximal Humeral Plate	1250-300	FDA UDI	Class I	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 36mm	8100-036	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 32cm	1310-032	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 45cm x 130°	1068-455	FDA UDI	Class II	Active
Aos Fracture Reduction Screw Humeral Nail	S1175	FDA UDI	Class II	Unknown
AOS TROCHANTERIC NAIL 11mm x 17cm x 120°	1082-170	FDA UDI	Class II	Active
AOS GALILEO™ LAG SCREW 10.5mm x 110mm	S1099-110	FDA UDI	Class II	Unknown
Ball Tip Depth Gauge	0519	FDA UDI	Class I	Active
Extractor Bolt	0828	FDA UDI	Class I	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 36mm	8081-036	FDA UDI	Class II	Active
Aos Fracture Reduction Screw Humeral Nail	1175	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.