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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 62 of 63
DeviceModel / ReferenceRegistriesClassStatus
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 30cm x 125° 1020-300
FDA UDI
Class IIActive
T-Handle Wrench 1154-100
FDA UDI
Class IActive
Fixed Small Axial Handle. Ao Quick Connect, Cannulated 5017-100
FDA UDI
Class IIActive
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 140mm x 10mm 1410-140
FDA UDI
Class IIActive
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø11mm x 39cm x 125° 1023-390
FDA UDI
Class IIActive
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 33cm x 130° S1069-335
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 42cm x 125° 1121-425
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL 12mm x 20cm x 130° S1041-200
FDA UDI
Class IIUnknown
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 48cm x 130° S1068-485
FDA UDI
Class IIUnknown
Trocar 0605-100
FDA UDI
Class IActive
AOS ANTEGRADE FEMORAL NAIL, RIGHT 10mm x 28cm S1311-028
FDA UDI
Class IIUnknown
AOS CORTICAL LOCKING SCREW 3.5mm x 32mm 8014-320
FDA UDI
Class IIActive
Non-Locking Screw, 4.0mm x 24mm 8085-024
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 60mm 8024-060
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 65mm 8028-065
FDA UDI
Class IIActive
AOS CORTICAL SCREW 3.5mm x 30.0mm S8010-300
FDA UDI
Class IIUnknown
Aos Set Screw, A/R 1085
FDA UDI
Class IIActive
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 44cm 1310-044
FDA UDI
Class IIActive
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 44mm 8024-044
FDA UDI
Class IIActive
AOS RETROGRADE FEMORAL NAIL 12mm x 38cm 1342-038
FDA UDI
Class IIActive
T-Handle Spacer 5045-000
FDA UDI
Class IIActive
Tibial Insertion Guide, Suprapatellar 1255-300
FDA UDI
Class IIActive
Guide Pin Depth Gauge, Femoral Nail 0534
FDA UDI
Class IActive
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 90mm S8061-090
FDA UDI
Class IIUnknown
MODULAR FLEXIBLE REAMER HEAD, Ø12.0mm 0234-120
FDA UDI
Class IIActive
AOS TIBIAL NAIL 12mm x 36.0cm 1112-360
FDA UDI
Class IIActive
AOS TROCHANTERIC NAIL, RIGHT 10mm x 36cm x 130° S1051-360
FDA UDI
Class IIUnknown
Targeting Module, Humeral Nail 1248
FDA UDI
Class IActive
Non-Locking Screw, 2.7mm x 16mm 8083-016
FDA UDI
Class IIActive
Aos Set Screw, A/R S1085
FDA UDI
Class IIUnknown
AOS TARGET CORTICAL SCREW 5.0mm x 7.5mm 8008-075
FDA UDI
Class IIActive
Non-Locking Screw, 2.4mm x 38mm 8082-038
FDA UDI
Class IIActive
Partially Threaded Screw, 4.0mm x 18mm 8086-018
FDA UDI
Class IIActive
TIBIAL NAIL SCREW Case Assembly 9904-020
FDA UDI
Class IActive
AOS Anterolateral Proximal Humeral Plate K160409
FDA 510(k)
Class IIActive
Aos Solid Locking Lag Screw, Aos Telescoping Lag Screw K120148
FDA 510(k)
Class IIActive
AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System K202489
FDA 510(k)
Class IIActive
External Fixation Clamp 5.0 Mm Pin X9.5mm Rod, Model 1151-100, External Fixaton Clamp, 9.5mm Rod K080408
FDA 510(k)
Class IIActive
Advanced Orthopaedic Solutions Trochanteric Nail K021008
FDA 510(k)
Class IIActive
Aos Proximal Humeral Plate K080590
FDA 510(k)
Class IIActive
Aos Cannulated Bone Screw System K014185
FDA 510(k)
Class IIActive
Trochanteric Nails And Es Trochanteric Nails, Humeral Naisl, Tibial Nails, Antegrade Femoral Nails, Retrograde Femoral N K133081
FDA 510(k)
Class IIActive
AOS Calcaneal Plating System K182466
FDA 510(k)
Class IIActive
Aos Tibial Nail K070444
FDA 510(k)
Class IIActive
Short Lateral Superior Clavicle Plate, Left And Right Model 3017-000 (left) And 3018-000 (right); 6 Hole Medium Midshaft K122623
FDA 510(k)
Class IIActive
AOS Anterolateral Proximal Humeral Plate K171606
FDA 510(k)
Class IIActive
AOS Small Fragment Plating System K152732
FDA 510(k)
Class IIActive
Aos Small Bone External Fixation, Threaded Half Pins, Aos Small Bone External Fixation, Carbon Fiber Rods, Aos Small Bon K141912
FDA 510(k)
Class IIActive
Aos Modular Femoral Nail K012190
FDA 510(k)
Class IIActive
AOS Small Bone Nailing System K163014
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

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.