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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 47 of 63
DeviceModel / ReferenceRegistriesClassStatus
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 28cm S1316-028
FDA UDI
Class IIUnknown
AOS CANCELLOUS SCREW 6.5mm x 70mm 8020-070
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 125mm 8061-125
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 65mm S8061-065
FDA UDI
Class IIUnknown
AOS MODULAR NAIL 13.0mm x 34cm 1013-340
FDA UDI
Class IIActive
AOS CALIBRATED DRILL 3.0mm x 200mm 0275
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 34cm S1318-034
FDA UDI
Class IIUnknown
AOS SMALL BONE REAMER Ø3.1 x 328mm 4020-031
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 40cm S1315-040
FDA UDI
Class IIUnknown
Proximal Lateral Tibia Plate, Right, 11 Hole 3082-111
FDA UDI
Class IIActive
Calcaneal Drop-In Tray 9947-000
FDA UDI
Class IIActive
Non-Locking Screw, 2.7mm x 28mm 8083-028
FDA UDI
Class IIActive
Trochanteric Nail Tray, Long 9902-004
FDA UDI
Class IActive
GALILEO® TROCHANTERIC NAIL, Ø12mm x 17cm x 130° 1041-170
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 28cm 1317-028
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 70mm S8059-070
FDA UDI
Class IIUnknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 40cm 1310-040
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 39cm x 125° 1120-395
FDA UDI
Class IIActive
AOS END CAP, ANTEGRADE FEMORAL NAIL 15.0mm 1322-015
FDA UDI
Class IIActive
3/16 Square Quick Connect 0486-100
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 130mm S8059-130
FDA UDI
Class IIUnknown
Trochanteric Nail Instruments Case Assembly 9914
FDA UDI
Class IActive
AOS THREADED HALF PIN (AO STYLE) 3.0mm x 100mm x 20mm 1416-100
FDA UDI
Class IIActive
Oblique T-Plate, Right, 3 x 3-Hole 3065-006
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 34cm 1311-034
FDA UDI
Class IIActive
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 8mm 8114-008
FDA UDI
Class IIActive
SCREW DRIVER, DISTAL TARGETING, TIBIAL NAIL 5.0mm 0435
FDA UDI
Class IActive
AOS CANNULATED BLOCKING SCREW 5.0mm x 95mm 8045-095
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 70mm 8001-070
FDA UDI
Class IIActive
AOS TIBIAL NAIL 11mm x 33.0cm S1111-330
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 33cm x 130° S1059-335
FDA UDI
Class IIUnknown
Distal Hook Plate, Medium, 5-Hole 3043-005
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 10mm x 32cm 1340-032
FDA UDI
Class IIActive
AOS GALILEO™ LAG SCREW 10.5mm x 85mm S1099-085
FDA UDI
Class IIUnknown
Retrograde Targeting Guide 1280
FDA UDI
Class IActive
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 34mm 8028-034
FDA UDI
Class IIActive
AOS CORTICAL SCREW 3.5mm x 10.0mm S8010-100
FDA UDI
Class IIUnknown
AOS Reamer Head, 16.5mm 0204-165
FDA UDI
Class IActive
ES™ RETROGRADE FEMORAL NAIL 12mm x 30cm 1392-030
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL, LEFT 11mm x 36cm x 125° S1022-360
FDA UDI
Class IIUnknown
Insert Reconstruction 1003
FDA UDI
Class IIActive
Semi-Tubular Plate, 21-Hole 3060-021
FDA UDI
Class IIActive
CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 105mm 8060-105
FDA UDI
Class IIActive
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 24mm 8114-024
FDA UDI
Class IIActive
AOS TIBIAL NAIL 13mm x 28.5cm S1113-285
FDA UDI
Class IIUnknown
AOS TROCHANTERIC NAIL 9mm x 17cm x 125° 1029-170
FDA UDI
Class IIActive
ES™ TROCHANTERIC NAIL, RIGHT, Ø10mm x 36cm x 125° 1021-365
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 75mm 8041-075
FDA UDI
Class IIActive
AOS CANNULATED CANCELLOUS SCREW, FULLY THREADED 7.0mm x 55mm 8042-055
FDA UDI
Class IIActive
Variable Angle Locking Screw, 3.5mm x 16mm 8088-016
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.