Is this your brand? Sign in to claim ownership.
Sign in to claim this brandADVANCED 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
- —
- —
- [email protected]
- Phone
- (310) 533-9966
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 117858154
Catalogue (3113)
Page 63 of 63| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Antegrade Femoral Nail | K123569 | FDA 510(k) | Class II | Active |
| Es Trochanteric Nail, Left And Right, 10mm | K103533 | FDA 510(k) | Class II | Active |
| AOS Clavicle Intramedullary Device | K143204 | FDA 510(k) | Class II | Active |
| Retrograde Femoral Nail | K132005 | FDA 510(k) | Class II | Active |
| AOS Small Fragment Plating System | K161913 | FDA 510(k) | Class II | Active |
| AOS Small Fragment Plating System Lite | K181035 | FDA 510(k) | Class II | Active |
| Aos 6.5mm Captured, Fully Threaded Cancellous Screw | K141228 | FDA 510(k) | Class II | Active |
| Lateral Superior Clavicle Plate, Left And Right; Midshaft Superior Clavicle Plate, Left And Right; Anterior Clavicle Pla | K103513 | FDA 510(k) | Class II | Active |
| 12mm And 13mm Tibial Nails | K130625 | FDA 510(k) | Class II | Active |
| Aos Humeral Nail | K050241 | FDA 510(k) | Class II | Active |
| AOS Galileo™ Trochanteric Nail System | K202099 | FDA 510(k) | Class II | Active |
| AOS ES Retrograde Femoral Nail | K191598 | FDA 510(k) | Class II | Active |
| Aos Proximal Humeral Nail | K090478 | FDA 510(k) | Class II | Active |
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.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 14, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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, 2010 | Z-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. |