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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 11 of 63
DeviceModel / ReferenceRegistriesClassStatus
AOS SUPRACONDYLAR FEMORAL NAIL 10mm x 22cm 1344-022
FDA UDI
Class IIActive
Targeting Module Tibial Nail 1238
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 34cm S1316-034
FDA UDI
Class IIUnknown
Non-Locking Screw, 3.5mm x 10mm 8084-010
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL, RIGHT 10mm x 42cm x 130° S1051-420
FDA UDI
Class IIUnknown
AOS CORTICAL SCREW 2.7mm x 18mm 8036-018
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 60mm 8041-060
FDA UDI
Class IIActive
AOS Trocar Tip Guide Wire, 1.5mm x 150mm 0109-150
FDA UDI
Class IActive
Trochanteric Nail Tray, 10mm x 125˚ 9902-018
FDA UDI
Class IActive
Variable Angle Locking Screw, 3.5mm x 80mm 8088-080
FDA UDI
Class IIActive
Anterolateral Distal Tibia Plate, Left, Medium, 19-Hole 3035-019
FDA UDI
Class IIActive
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 110mm 1045-110
FDA UDI
Class IIActive
TROCHANTERIC NAIL TRAY, Ø12.5mm x 130° 9902-021
FDA UDI
Class IIActive
AOS HUMERAL NAIL 7.0mm x 25cm 1171-250
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 40cm 1315-040
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 13mm x 28cm 1343-028
FDA UDI
Class IIActive
AOS CANCELLOUS LAG SCREW 4.0mm x 30mm 8032-030
FDA UDI
Class IIActive
AOS CANCELLOUS SCREW 5.0mm x 85mm S8022-085
FDA UDI
Class IIUnknown
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 26mm 8124-026
FDA UDI
Class IIActive
AOS CLAVICLE INTRAMEDULLARY DEVICE 2.7mm x 80mm 1335-080
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 60mm S8061-060
FDA UDI
Class IIUnknown
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 22mm 8103-022
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 55mm S8065-055
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 42cm x 130° 1068-425
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL 11mm x 17cm x 125° 1031-170
FDA UDI
Class IIActive
Locking Bolt Antegrade Femoral Nail 1273-100
FDA UDI
Class IActive
Lag Screw Capturing Rod 0462
FDA UDI
Class IActive
AOS END CAP, TIBIAL NAIL 10mm S1115-100
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 48cm x 125° S1023-485
FDA UDI
Class IIUnknown
AOS CANCELLOUS LOCKING SCREW 4.0mm x 28mm 8023-028
FDA UDI
Class IIActive
Lite Semi-Tubular Plate, 11-Hole 3060-911
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 38cm 1313-038
FDA UDI
Class IIActive
CORTICAL SCREW 3.5mm x 18.0mm 8010-180
FDA UDI
Class IIActive
Targeter Alignment Post 4918-000
FDA UDI
Class IIActive
Cannulated Headless Compression Screw, 1/4 Threaded, 3.5mm x 40mm 8080-040
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 75mm S8060-075
FDA UDI
Class IIUnknown
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 34mm 8124-034
FDA UDI
Class IIActive
AOS MODULAR NAIL 11.0mm x 30cm 1011-300
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 54mm 8024-054
FDA UDI
Class IIActive
Partially Threaded Screw, 4.0mm x 22mm 8086-022
FDA UDI
Class IIActive
CORTICAL LOCKING SCREW 3.5mm x 12mm 8012-120
FDA UDI
Class IIActive
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 60mm 8103-060
FDA UDI
Class IIActive
Straight Plate, 11-Hole 3061-011
FDA UDI
Class IIActive
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 30mm 8031-030
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 12mm x 28cm S1314-028
FDA UDI
Class IIUnknown
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 40mm 8114-040
FDA UDI
Class IIActive
Guide Wire Gripper 0481-100
FDA UDI
Class IIActive
7.0mm Solid Hex Driver, Galileo™ Explant 0851
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 48cm 1310-048
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 48cm x 130° 1069-485
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.