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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 42 of 63
DeviceModel / ReferenceRegistriesClassStatus
AOS TROCHANTERIC NAIL, RIGHT 10mm x 30cm x 130° 1051-300
FDA UDI
Class IIActive
AOS TIBIAL NAIL 10mm x 39.0cm S1110-390
FDA UDI
Class IIUnknown
CANNULATED ENTRY REAMER 10.5mm S0221
FDA UDI
Class IActive
AOS Reamer Head, 10.5mm 0204-105
FDA UDI
Class IActive
Capturing Rod Nut, Galileo® Lag Screw 5046-000
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW 4.0mm x 46mm 8023-046
FDA UDI
Class IIActive
1.9mm Drill Guide, Ankle Plate 0348
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 30cm 1316-030
FDA UDI
Class IIActive
Variable Angle Locking Screw, 3.5mm x 44mm 8088-044
FDA UDI
Class IIActive
Lateral Distal Fibula Plate, Xl, 18-Hole, Left 3051-018
FDA UDI
Class IIActive
AOS Trocar Tip Guide Wire, 2.0mm x 508mm 0102-500
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 32cm 1311-032
FDA UDI
Class IIActive
Reduction Tool Humeral Nail 0807
FDA UDI
Class IActive
ES™ TROCHANTERIC NAIL TRAY, 10mm x 130° 9902-016
FDA UDI
Class IActive
Proximal Humeral Plate System, Case Assembly 9912-100
FDA UDI
Class IActive
Exchange Tube 0809
FDA UDI
Class IActive
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 120mm S8061-120
FDA UDI
Class IIUnknown
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 70mm 8042-070
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 48cm x 130° 1123-480
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 32cm 1316-032
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 36cm 1191-365
FDA UDI
Class IIActive
AOS THREADED HALF PIN (AO STYLE) 5.0mm x 220mm x 60mm 1160-226
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 70mm 8081-070
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 4.2mm x 55mm S8002-055
FDA UDI
Class IIUnknown
MODULAR FLEXIBLE REAMER HEAD, Ø14.5mm 0234-145
FDA UDI
Class IIActive
CORTICAL SCREW 3.5mm x 12.0mm 8010-120
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 150mm 8041-150
FDA UDI
Class IIActive
Anterior Cortical Rim Plate, 5-Hole 3040-005
FDA UDI
Class IIActive
Instrument Set 2, Trochanteric Nail System 9914-200
FDA UDI
Class IIActive
Ø2.8mm DRILL GUIDE, DOUBLE LEAD 0324-500
FDA UDI
Class IIActive
Proximal Lateral Tibia Plate, Right, 14 Hole 3082-114
FDA UDI
Class IIActive
Variable Angle Locking Screw, 3.5mm x 30mm 8088-030
FDA UDI
Class IIActive
Hook Tip Depth Gauge, Ankle Plate 0543
FDA UDI
Class IActive
CORTICAL SCREW 3.5mm x 35.0mm 8010-350
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 13mm x 32cm 1343-032
FDA UDI
Class IIActive
AOS ANTI-ROTATION SCREW 5.0mm x 60mm 8021-060
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 22mm 8080-022
FDA UDI
Class IIActive
Aos Clavicle Plate, Midshaft Superior 6 Hole Straight, Left 3019-060
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL 12mm x 20cm x 125° 1032-200
FDA UDI
Class IIActive
AOS ANTI-ROTATION SCREW 5.0mm x 105mm 8021-105
FDA UDI
Class IIActive
CORTICAL SCREW 3.5mm x 55.0mm 8010-550
FDA UDI
Class IIActive
Targeting Arm 1275
FDA UDI
Class IActive
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 75mm x 15mm 1411-075
FDA UDI
Class IIActive
Captured T10 Screwdriver, Short 5025-200
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 135mm 8059-135
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 30mm 8081-030
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 30mm S8061-030
FDA UDI
Class IIUnknown
AOS Reamer Head, 17.5mm 0204-175
FDA UDI
Class IActive
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 110mm 8041-110
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 70mm 8061-070
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.