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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 17 of 63

Device	Model / Reference	Registries	Class	Status
AOS TIBIAL NAIL 11mm x 28.5cm	1111-285	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 60mm	8114-060	FDA UDI	Class II	Active
AOS Calibrated Drill, AO Style, 4.0mm x 280mm	0219-100	FDA UDI	Class I	Active
AOS CANCELLOUS TAP 3.5mm	0255-200	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 48cm	S1317-048	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 30mm	8060-030	FDA UDI	Class II	Active
AOS TIBIAL NAIL 10mm x 28.5cm	S1110-285	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 100mm	S8061-100	FDA UDI	Class II	Unknown
AOS END CAP, MODULAR NAIL 1.0mm	1015-010	FDA UDI	Class II	Active
AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 120mm	1335-120	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 50.0mm	8022-050	FDA UDI	Class II	Active
AOS Screw Capturing Rod Long	0434	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL 11mm x 17cm x 125°	S1031-170	FDA UDI	Class II	Unknown
AOS CANNULATED BLOCKING SCREW 5.0mm x 85mm	S8045-085	FDA UDI	Class II	Unknown
FORWARD CUTTING MONOBLOC REAMER, HUDSON, Ø8.0mm	0251-080	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 32.5mm	S8002-032	FDA UDI	Class II	Unknown
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 135mm	8065-135	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 115mm	8065-115	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 30cm	S1310-030	FDA UDI	Class II	Unknown
Soft Tissue Protector	0610	FDA UDI	Class I	Active
AOS PARALLEL PIN GUIDE, BULLET NOSE 3.2mm	0322	FDA UDI	Class I	Active
Variable Angle Locking Screw, 3.5mm x 75mm	8088-075	FDA UDI	Class II	Active
AOS TIBIAL NAIL 12mm x 27.0cm	1112-270	FDA UDI	Class II	Active
ES™ RETROGRADE FEMORAL NAIL 10mm x 40cm	1390-040	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 50mm	8028-050	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 36mm	8012-360	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 39cm x 130°	1069-395	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 45cm x 130°	1058-455	FDA UDI	Class II	Active
Impactor Pad	0808-200	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 30cm x 130°	1122-305	FDA UDI	Class II	Active
CARBON FIBER ROD, Ø9.5mm x 150mm	1152-150	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 28mm	8114-028	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, Ø9mm x 20cm x 130°	1034-200	FDA UDI	Class II	Active
AOS SOLID LOCKING LAG SCREW 10.5mm x 75mm	S1094-075	FDA UDI	Class II	Unknown
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 45mm	8041-045	FDA UDI	Class II	Active
AOS PIN GUIDE, ENTRY TUBE 3.2mm	0310	FDA UDI	Class I	Active
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 110mm	1192-110	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 30cm	1315-030	FDA UDI	Class II	Active
AOS SOLID LOCKING LAG SCREW 10.5mm x 70mm	1094-070	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 5.0mm x 38mm	S8001-038	FDA UDI	Class II	Unknown
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 22mm	8028-022	FDA UDI	Class II	Active
AOS CANCELLOUS LAG SCREW 4.0mm x 28mm	8032-028	FDA UDI	Class II	Active
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 140mm x 10mm	1414-140	FDA UDI	Class II	Active
AOS END CAP, RETROGRADE FEMORAL NAIL 10mm	1339-010	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 36cm x 125°	1120-365	FDA UDI	Class II	Active
Reduction Bolt, Extended Tibial Insertion Guide	1257	FDA UDI	Class I	Active
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 110mm	1092-110	FDA UDI	Class II	Active
Variable Angle Locking Screw, 2.7mm x 44mm	8087-044	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 10mm	8100-010	FDA UDI	Class II	Active
TARGETING MODULE, TROCHANTERIC NAIL 135°/20cm	1223-100	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.