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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 33 of 63
DeviceModel / ReferenceRegistriesClassStatus
AOS CORTICAL SCREW 2.7mm x 10mm 8036-010
FDA UDI
Class IIActive
Insert Standard Threaded 1005-100
FDA UDI
Class IIActive
Impactor Pad 0837
FDA UDI
Class IActive
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 85mm 8100-085
FDA UDI
Class IIActive
AOS DRILL GUIDE 2.0mm 0325-200
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 40cm 1317-040
FDA UDI
Class IIActive
AOS HUMERAL NAIL 8mm x 30.0cm S1172-300
FDA UDI
Class IIUnknown
AOS MODULAR NAIL 10.0mm x 40cm 1010-400
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 30mm 8042-030
FDA UDI
Class IIActive
AOS MODULAR NAIL 13.0mm x 32cm 1013-320
FDA UDI
Class IIActive
Aos Spacer, Static Locking Tibial Nail 1117
FDA UDI
Class IIActive
Lateral Distal Fibula Plate, Xxl, 21-Hole, Right 3052-021
FDA UDI
Class IIActive
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 95mm 1099-095
FDA UDI
Class IIActive
CORTICAL LOCKING SCREW 3.5mm x 22mm 8012-220
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 11mm x 44cm 1341-044
FDA UDI
Class IIActive
AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 100mm 1335-100
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 70mm S8001-070
FDA UDI
Class IIUnknown
Insertion Guide Humeral Nail 1230
FDA UDI
Class IActive
GUIDE PIN, Ø3.2mm x 381mm S0100-381
FDA UDI
Class IIActive
TROCHANTERIC IMPLANT Case #2 Assembly 9900-102
FDA UDI
Class IActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 45mm S8060-045
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 36cm x 130° 1068-365
FDA UDI
Class IIActive
AOS TIBIAL NAIL 10mm x 28.5cm 1110-285
FDA UDI
Class IIActive
AOS END CAP, ANTEGRADE FEMORAL NAIL 15.0mm S1322-015
FDA UDI
Class IIUnknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 30cm S1312-030
FDA UDI
Class IIUnknown
AOS ScrewGripper 3.5mm/4.0mm Screws 0433
FDA UDI
Class IActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 135mm S8060-135
FDA UDI
Class IIUnknown
Aos Condyle Fixation Nut Retrograde Femoral Nail 1348
FDA UDI
Class IIActive
CARBON FIBER ROD, Ø9.5mm x 200mm 1152-200
FDA UDI
Class IIActive
CORTICAL TAP, LARGE HUDSON 5.0mm S0260
FDA UDI
Class IActive
Lamina Spreader, Ankle Plate 0907
FDA UDI
Class IActive
CORTICAL LOCKING SCREW 3.5mm x 16mm 8014-160
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 75mm 8065-075
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 70mm 8028-070
FDA UDI
Class IIActive
ES™ TROCHANTERIC NAIL, RIGHT, Ø11mm x 30cm x 125° 1023-305
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL, LEFT 12.5mm x 36cm x 130° S1122-360
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, LEFT 10mm x 45cm x 130° 1066-455
FDA UDI
Class IIActive
GALILEO® LEFTY TIGHTY™ CRT²™ LAG SCREW, LEFT, 10.5mm x 120mm 1192-120
FDA UDI
Class IIActive
Aos Lateral Superior Clavicle Plate Medium, Left 3003-040
FDA UDI
Class IIActive
Anterolateral Distal Tibia Plate, Right, Medium, 19-Hole 3036-019
FDA UDI
Class IIActive
AOS TIBIAL NAIL 13mm x 36.0cm S1113-360
FDA UDI
Class IIUnknown
GUIDE PIN, Ø3.2mm x 330mm 0100-000
FDA UDI
Class IIActive
TOMMY BAR 5.0mm 1208
FDA UDI
Class IActive
Radiolucent Targeting Arm, Calcaneal Plate, Right, Extra Small 4907-010
FDA UDI
Class IIActive
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 55mm x 15mm 1412-075
FDA UDI
Class IIActive
5.0mm COMPRESSION HEX DRIVER, LARGE HUDSON FEMORAL NAIL 0487
FDA UDI
Class IActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 20mm 8001-020
FDA UDI
Class IIActive
Non-Locking Screw, 2.4mm x 24mm 8082-024
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 46cm 1317-046
FDA UDI
Class IIActive
Lite Straight Plate, 11-Hole 3061-911
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

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.