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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 56 of 63
DeviceModel / ReferenceRegistriesClassStatus
Small Tenaculum, Pointed Tips Ratcheted 0910
FDA UDI
Class IActive
AOS TROCHANTERIC NAIL, RIGHT 11mm x 42cm x 130° 1059-420
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 95mm 8042-095
FDA UDI
Class IIActive
FORWARD CUTTING MONOBLOC REAMER, HUDSON, Ø7.5mm 0251-075
FDA UDI
Class IIActive
AOS MODULAR NAIL 11.0mm x 46cm 1011-460
FDA UDI
Class IIActive
AOS PIN GUIDE, SCREW SHEATH 3.2mm 0306
FDA UDI
Class IActive
AOS OBTURATOR 3.6mm 0273
FDA UDI
Class IActive
CALIBRATED DRILL 2.0mm x 110mm 4002
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 38cm S1314-038
FDA UDI
Class IIUnknown
Aos 95° Proximal Humeral Plate 3 Hole 3022-003
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 36cm S1319-036
FDA UDI
Class IIUnknown
AOS DRILL GUIDE 2.5mm 0324-200
FDA UDI
Class IActive
Aos Lateral Superior Clavicle Plate Straight, Left 3003-060
FDA UDI
Class IIActive
Solid T15 Driver, Retaining 0448-400
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 22mm 8081-022
EUDAMEDFDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 42cm x 125° 1120-425
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 36cm 1316-036
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 34cm 1308-034
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 32cm S1308-032
FDA UDI
Class IIUnknown
AOS CANCELLOUS SCREW 5.0mm x 32.5mm 8022-032
FDA UDI
Class IIActive
AOS END CAP, ANTEGRADE FEMORAL NAIL 5.0mm S1322-005
FDA UDI
Class IIUnknown
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 48cm S1311-048
FDA UDI
Class IIUnknown
AOS HUMERAL NAIL 8.0mm x 32.5cm 1172-325
FDA UDI
Class IIActive
CORTICAL SCREW 3.5mm x 45.0mm 8010-450
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW 4.0mm x 22mm 8023-022
FDA UDI
Class IIActive
Lite Straight Plate, 13-Hole 3061-913
FDA UDI
Class IIActive
Posterior Distal Fibula Plate, Right, Short, 9-Hole 3054-009
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 44cm 1313-044
FDA UDI
Class IIActive
Anterolateral Distal Tibia Plate, Left, Long, 23-Hole 3035-023
FDA UDI
Class IIActive
GALILEO® LAG SCREW, LEFT, 10.5mm x 125mm 1199-125
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW 4.0mm x 30mm 8023-030
FDA UDI
Class IIActive
Semi-Tubular Plate, 19-Hole 3060-019
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 65mm 8081-065
FDA UDI
Class IIActive
AOS HUMERAL NAIL 9mm x 25.0cm S1173-250
FDA UDI
Class IIUnknown
LITE T-PLATE, 2x3-HOLE 3062-905
FDA UDI
Class IIActive
Non-Locking Screw, 2.7mm x 36mm 8083-036
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 30cm 1308-030
FDA UDI
Class IIActive
Calibrated Drill, AO Style, 3.5mm x 180mm 0220-100
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 42cm S1319-042
FDA UDI
Class IIUnknown
AOS CANCELLOUS SCREW 6.5mm x 75mm 8020-075
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 4.2mm x 25mm S8002-025
FDA UDI
Class IIUnknown
Partially Threaded Screw, 4.0mm x 70mm 8086-070
FDA UDI
Class IIActive
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 95mm 1045-095
FDA UDI
Class IIActive
AOS SOLID LOCKING LAG SCREW 10.5mm x 120mm 1094-120
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 28cm 1319-028
FDA UDI
Class IIActive
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 16mm 8103-016
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 46mm 8081-046
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 38cm 1317-038
FDA UDI
Class IIActive
LOCKING GUIDE, DISTAL TARGETING 12mm Tibial Nail 1264-012
FDA UDI
Class IActive
AOS CORTICAL LOCKING SCREW 2.7mm x 16mm 8030-016
FDA UDI
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

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.