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ADVANCED ORTHOPAEDIC SOLUTIONS, INC.

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: —
Email: [email protected]
Phone: (310) 533-9966
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 117858154

Catalogue (3113)

Page 36 of 63

Device	Model / Reference	Registries	Class	Status
CANNULATED HIP SCREW DRILL, LARGE HUDSON 10.3mm	S0258	FDA UDI	Class I	Active
AOS THREADED HALF PIN (AO STYLE) 5.0mm x 220mm x 50mm	1160-220	FDA UDI	Class II	Active
AOS Reamer Head, 18.0mm	0204-180	FDA UDI	Class I	Active
REAMER HEAD 9.5mm	0223-095	FDA UDI	Class I	Active
AOS ANTI-ROTATION SCREW 5.0mm x 65mm	8021-065	FDA UDI	Class II	Active
AOS CLAVICLE INTRAMEDULLARY DEVICE 4.0mm x 80mm	1302-080	FDA UDI	Class II	Active
AOS TIBIAL NAIL 10mm x 34.5cm	S1110-345	FDA UDI	Class II	Unknown
Depth Gauge Tip	0500-003	FDA UDI	Class I	Active
AOS TROCHANTERIC NAIL, LEFT 11mm x 39cm x 125°	S1022-390	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 60mm	S8059-060	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 11mm x 30.0cm	1111-300	FDA UDI	Class II	Active
AOS SOLID LOCKING LAG SCREW 10.5mm x 115mm	S1094-115	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 55mm	8059-055	FDA UDI	Class II	Active
AOS Calibrated Drill 6.5mm x 260mm	0246	FDA UDI	Class I	Active
Lateralizer	0806	FDA UDI	Class I	Active
AOS Reamer Head, 13.5mm	0204-135	FDA UDI	Class I	Active
AOS SMALL BONE REAMER Ø3.7 x 328mm	4020-037	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 90mm	8041-090	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 24mm	8103-024	FDA UDI	Class II	Active
TROCAR TIP GUIDE WIRE 2.0mm x 300mm	S0102-300	FDA UDI	Class I	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 50mm	8041-050	FDA UDI	Class II	Active
Non-Locking Screw, 4.0mm x 38mm	8085-038	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 32cm	1317-032	FDA UDI	Class II	Active
Captured T10 Screwdriver, Short	5025-100	FDA UDI	Class I	Active
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 20mm	8024-020	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 14mm x 42cm x 130°	S1069-425	FDA UDI	Class II	Unknown
AOS MODULAR NAIL 10.0mm x 20cm	1010-200	FDA UDI	Class II	Active
AOS GALILEO™ LAG SCREW 10.5mm x 120mm	S1099-120	FDA UDI	Class II	Unknown
AOS TIBIAL NAIL 12mm x 27.0cm	S1112-270	FDA UDI	Class II	Unknown
AOS RETROGRADE FEMORAL NAIL 13mm x 26cm	1343-026	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 38cm	1318-038	FDA UDI	Class II	Active
Extractor	0815	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 14mm x 48cm	S1319-048	FDA UDI	Class II	Unknown
Radiolucent Targeting Arm, Calcaneal Plate, Right, Large	4907-060	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 30mm	8110-030	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 105mm	S8059-105	FDA UDI	Class II	Unknown
Medial Pilon Plate, Xl, 25-Hole, Left	3031-025	FDA UDI	Class II	Active
Aos Parallel Fixation Nut	1428	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 10mm x 38cm	1310-038	FDA UDI	Class II	Active
HEX DRIVER 5.0mm	0450	FDA UDI	Class I	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 35mm	8040-035	FDA UDI	Class II	Active
AOS SMALL BONE REAMER Ø5.1 x 328mm	4020-051	FDA UDI	Class II	Active
AOS TIBIAL NAIL 9mm x 37.5cm	1109-375	FDA UDI	Class II	Active
AOS SUPRACONDYLAR FEMORAL NAIL 11mm x 22cm	1345-022	FDA UDI	Class II	Active
Non-Locking Screw, 3.5mm x 32mm	8084-032	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL 13mm x 17cm x 125°	S1033-170	FDA UDI	Class II	Unknown
GALILEO™ LAG SCREW, RIGHT, 10.5mm x 85mm	1099-085	FDA UDI	Class II	Active
AOS CORTICAL SCREW 2.7mm x 14mm	8036-014	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 30mm	8040-030	FDA UDI	Class II	Active
OBTURATOR, Ø3.2mm PIN GUIDE	0616-000	FDA UDI	Class II	Active

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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.

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.