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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 12 of 63
DeviceModel / ReferenceRegistriesClassStatus
AOS CAPTURED CORTICAL SCREW 5.0mm x 30mm S8001-030
FDA UDI
Class IIUnknown
RATCHETING TORQUE LIMITING HANDLE, 1.7Nm, AO 5027
FDA UDI
Class IActive
AOS THREADED HALF PIN (AO STYLE) 5.0mm x 220mm x 20mm 1160-222
FDA UDI
Class IIActive
AOS DRILL GUIDE 6.0mm 0339
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 30cm 1319-030
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 40mm 8081-040
FDA UDI
Class IIActive
3.5mm HEX SCREWDRIVER 0417-100
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 48cm x 125° 1121-485
FDA UDI
Class IIActive
Cortical Screw, 5.0mm x 50mm 8000-050
FDA UDI
Class IIActive
CANNULATED ENTRY REAMER, HUDSON 12.0mm S0228-100
FDA UDI
Class IActive
AOS CORTICAL SCREW 2.7mm x 34mm 8036-034
FDA UDI
Class IIActive
AOS CANCELLOUS SCREW 5.0mm x 60mm S8022-060
FDA UDI
Class IIUnknown
AOS SOLID LOCKING LAG SCREW 10.5mm x 130mm 1094-130
FDA UDI
Class IIActive
AOS CANCELLOUS LAG SCREW 4.0mm x 40mm 8032-040
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW 4.0mm x 54mm 8023-054
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 42cm x 130° 1069-425
FDA UDI
Class IIActive
Non-Locking Screw, 3.5mm x 18mm 8084-018
FDA UDI
Class IIActive
Compression Sleeve, Lag Screw Inserter 125° 0465-100
FDA UDI
Class IActive
T-Handle Wrench 1154
FDA UDI
Class IActive
Fibonacci™ Proximal Posteromedial Tibia Plate, Right, 5 Hole 3086-005
FDA UDI
Class IIActive
T10 Driver, Retaining 5042-100
FDA UDI
Class IIActive
Aos Clavicle Plate, Short Lateral Superior, Left 3017
FDA UDI
Class IIActive
ES™ TROCHANTERIC NAIL, LEFT, Ø10mm x 30cm x 125° 1020-305
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 40cm S1314-040
FDA UDI
Class IIUnknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 9mm x 44cm S1308-044
FDA UDI
Class IIUnknown
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 35mm S8065-035
FDA UDI
Class IIUnknown
AOS TIBIAL NAIL 11mm x 28.5cm S1111-285
FDA UDI
Class IIUnknown
Extractor Bolt Trochanteric Nail 0802-100
FDA UDI
Class IActive
AOS PIN GUIDE, SOFT TISSUE PROTECTOR 3.2mm 0338
FDA UDI
Class IActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 75mm 8081-075
FDA UDI
Class IIActive
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 42mm 8100-042
FDA UDI
Class IIActive
Fibonacci™ Proximal Lateral Tibia Plate, Left, 11 Hole 3081-011
FDA UDI
Class IIActive
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 30mm 8114-030
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 45cm x 130° 1069-455
FDA UDI
Class IIActive
AOS CANCELLOUS SCREW 5.0mm x 55.0mm 8022-055
FDA UDI
Class IIActive
AOS DRILL GUIDE 4.0mm 0308-200
FDA UDI
Class IActive
Cannulated Curved Awl, T-Handle 0256-000
FDA UDI
Class IIActive
Aos Fixation Nut Washer Retrograde Femoral Nail 1351
FDA UDI
Class IIActive
AOS CANNULATED BLOCKING SCREW 5.0mm x 65mm 8045-065
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 4.2mm x 70.0mm 8002-070
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 26mm 8081-026
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 54mm 8028-054
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 36cm 1310-036
FDA UDI
Class IIActive
AOS TIBIAL NAIL 13mm x 34.5cm 1113-345
FDA UDI
Class IIActive
Queen Tong Forceps 0908
FDA UDI
Class IActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 105mm S8001-105
FDA UDI
Class IIUnknown
ES™ RETROGRADE FEMORAL NAIL 12mm x 38cm 1392-038
FDA UDI
Class IIActive
Posterior Distal Fibula Plate, Right, Long, 12-Hole 3054-012
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 4.2mm x 65.0mm 8002-065
FDA UDI
Class IIActive
AOS SOLID LOCKING LAG SCREW 10.5mm x 80mm S1094-080
FDA UDI
Class IIUnknown

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.