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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 19 of 63
DeviceModel / ReferenceRegistriesClassStatus
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 95mm 8065-095
FDA UDI
Class IIActive
AOS THREADED HALF PIN (AO STYLE) 5.0mm x 180mm x 40mm 1160-184
FDA UDI
Class IIActive
T15 Solid Hex Driver 0448-200
FDA UDI
Class IActive
Partially Threaded Screw, 4.0mm x 32mm 8086-032
FDA UDI
Class IIActive
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 140mm x 25mm 1413-140
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 32mm S8001-032
FDA UDI
Class IIUnknown
Tibial Nail Instruments Tray 9920
FDA UDI
Class IActive
ES™ TROCHANTERIC NAIL, LEFT, Ø11mm x 39cm x 125° 1022-395
FDA UDI
Class IIActive
AOS HUMERAL NAIL 7mm x 20.0cm S1171-200
FDA UDI
Class IIUnknown
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 45mm 8059-045
FDA UDI
Class IIActive
CARBON FIBER ROD, Ø5.0mm x 300mm 1181-300
FDA UDI
Class IIActive
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 42cm x 125° 1021-420
FDA UDI
Class IIActive
AOS CANNULATED BLOCKING SCREW 5.0mm x 60mm S8045-060
FDA UDI
Class IIUnknown
AOS TIBIAL NAIL 9mm x 37.5cm S1109-375
FDA UDI
Class IIUnknown
AOS CANCELLOUS TAP 3.5mm 0255-100
FDA UDI
Class IActive
FORWARD CUTTING MONOBLOC REAMER, HUDSON, Ø8.5mm 0251-085
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 13mm x 36cm 1343-036
FDA UDI
Class IIActive
GALILEO® LAG SCREW, LEFT, 10.5mm x 95mm 1199-095
FDA UDI
Class IIActive
T-Plate, 2 x 3-Hole 3062-005
FDA UDI
Class IIActive
AOS CAPTURED CORTICAL SCREW 5.0mm x 42mm 8001-042
FDA UDI
Class IIActive
Retrograde Femoral Nail Case 10mm-11mm 9927
FDA UDI
Class IActive
AOS CORTICAL SCREW 3.5mm x 25.0mm S8010-250
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 36cm x 130° S1068-365
FDA UDI
Class IIUnknown
Fixed Large Axial Handle W/ Impact Cap, Cannulated 0467-100
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 10mm x 36cm x 130° 1067-365
FDA UDI
Class IIActive
CORTICAL LOCKING SCREW 3.5mm x 8mm 8012-080
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 50mm 8060-050
FDA UDI
Class IIActive
PIN GUIDE, BLOCKING SCREW TARGETING ARM 2.0mm 1243
FDA UDI
Class IActive
ES™ TROCHANTERIC NAIL, RIGHT, Ø11mm x 36cm x 125° 1023-365
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 115mm 8061-115
FDA UDI
Class IIActive
AOS CANCELLOUS SCREW 5.0mm x 42.5mm S8022-042
FDA UDI
Class IIUnknown
Cortical Tap, AO Style, 2.7mm, Ankle Plate 4023
FDA UDI
Class IActive
AOS CORTICAL LOCKING SCREW 3.5mm x 38mm 8014-380
FDA UDI
Class IIActive
Variable Angle Locking Screw, 2.7mm x 38mm 8087-038
FDA UDI
Class IIActive
AOS CLAMP 9.5mm ROD x 9.5mm ROD 1151-200
FDA UDI
Class IIActive
Variable Angle Locking Screw, 2.7mm x 32mm 8087-032
FDA UDI
Class IIActive
Posterior Distal Fibula Plate, Left, Long, 12-Hole 3053-012
FDA UDI
Class IIActive
AOS PROXIMAL HUMERAL NAIL 8.0mm x 15cm 1170-150
FDA UDI
Class IIActive
ES™ RETROGRADE FEMORAL NAIL 11mm x 30cm 1391-030
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 70mm 8065-070
FDA UDI
Class IIActive
AOS CANCELLOUS SCREW 5.0mm x 22.5mm S8022-022
FDA UDI
Class IIUnknown
MODULAR FLEXIBLE REAMER HEAD, Ø15.5mm 0234-155
FDA UDI
Class IIActive
Radiolucent Targeting Arm, Calcaneal Plate, Left, Small 4906-020
FDA UDI
Class IIActive
AOS THREADED HALF PIN (AO STYLE) 5.0mm x 220mm x 70mm 1160-227
FDA UDI
Class IIActive
AOS CORTICAL SCREW 2.7mm x 32mm 8036-032
FDA UDI
Class IIActive
MODULAR FLEXIBLE REAMER HEAD, Ø13.5mm 0234-135
FDA UDI
Class IIActive
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 100mm 1092-100
FDA UDI
Class IIActive
OBTURATOR 4.0mm 4038-000
FDA UDI
Class IIActive
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 75mm S8061-075
FDA UDI
Class IIUnknown
Non-Locking Screw, 2.7mm x 50mm 8083-050
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.