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ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

US

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
—
Phone
(310) 533-9966
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
117858154

Catalogue (3113)

Page 30 of 63
DeviceModel / ReferenceRegistriesClassStatus
Galileo® Locking Tool 5031-000
FDA UDI
Class IIActive
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 90mm 8060-090
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 38cm 1316-038
FDA UDI
Class IIActive
AOS ANTI-ROTATION SCREW 5.0mm x 95mm S8021-095
FDA UDI
Class IIUnknown
AOS HEX DRIVER - SHORT 3.5mm 0400-300
FDA UDI
Class IActive
Proximal Lateral Tibia Plate, Right, 8 Hole 3082-108
FDA UDI
Class IIActive
Tibial Nail 11mm x 40.5cm 1111-405
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 48cm S1314-048
FDA UDI
Class IIUnknown
AOS LAG SCREW 10.5mm x 95mm S1045-095
FDA UDI
Class IIUnknown
ES™ TROCHANTERIC NAIL, LEFT, 12.5mm x 42cm x 125 GOLD 1190-425
FDA UDI
Class IIActive
Calibrated Drill, AO Style, 2.5mm x 200mm 4016
FDA UDI
Class IIActive
Lite Straight Plate, 7-Hole 3061-907
FDA UDI
Class IIActive
Non-Locking Screw, 2.4mm x 26mm 8082-026
FDA UDI
Class IIActive
HEX DRIVER, FRACTURE REDUCTION SCREW 3.5mm 0458
FDA UDI
Class IActive
AOS SMALL BONE REAMER Ø3.4 x 328mm 4020-034
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 24mm 8081-024
FDA UDI
Class IIActive
3.5mm HEX SCREWDRIVER, LONG 0471-000
FDA UDI
Class IIActive
4.0mm CORTICAL TAP (AO STYLE) 4029
FDA UDI
Class IIActive
AOS Hex Driver 2.5mm 0416-100
FDA UDI
Class IActive
AOS TROCHANTERIC NAIL, RIGHT 11mm x 36cm x 130° S1059-360
FDA UDI
Class IIUnknown
AOS CANCELLOUS SCREW 5.0mm x 70.0mm 8022-070
FDA UDI
Class IIActive
ENTRY TUBE 13.0mm 0612-100
FDA UDI
Class IActive
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 95mm 8059-095
FDA UDI
Class IIActive
SOLID HEX DRIVER 2.5mm 0448
FDA UDI
Class IActive
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 120mm 8040-120
FDA UDI
Class IIActive
Non-Locking Screw, 4.0mm x 40mm 8085-040
FDA UDI
Class IIActive
Partially Threaded Screw, 4.0mm x 36mm 8086-036
FDA UDI
Class IIActive
Jig Locking Bolt Trochanteric Nail 1221
FDA UDI
Class IActive
Lite Straight Plate, 21-Hole 3061-921
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 30cm x 125° S1023-305
FDA UDI
Class IIUnknown
Non-Locking Screw, 3.5mm x 44mm 8084-044
FDA UDI
Class IIActive
Posterior Distal Tibia Plate , Left 3041-009
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 11mm x 34cm 1341-034
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 40mm 8040-040
FDA UDI
Class IIActive
Comfort T-Handle, Cannulated, Large Hudson Adapter 0468-100
FDA UDI
Class IIActive
Variable Angle Locking Screw, 3.5mm x 32mm 8088-032
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 30mm 8080-030
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 40cm 1314-040
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 60mm S8001-060
FDA UDI
Class IIUnknown
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 44cm 1315-044
FDA UDI
Class IIActive
Bending Iron, Ankle Plate 0843
FDA UDI
Class IActive
AOS Reamer Head, 13.0mm 0204-130
FDA UDI
Class IActive
AOS CANCELLOUS SCREW 5.0mm x 27.5mm 8022-027
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 20mm 8080-020
FDA UDI
Class IIActive
AOS ANTI-ROTATION SCREW 5.0mm x 85mm S8021-085
FDA UDI
Class IIUnknown
REAMER HEAD 8.5mm 0223-085
FDA UDI
Class IActive
ELEVATOR, 5mm PERIOSTEAL 0911-100
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 115mm 8042-115
FDA UDI
Class IIActive
AOS CANCELLOUS SCREW 5.0mm x 75.0mm 8022-075
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 30cm S1308-030
FDA UDI
Class IIUnknown

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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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.

DateRecall No.ClassStatusReason
Jan 14, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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, 2010Z-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.