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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 16 of 63

Device	Model / Reference	Registries	Class	Status
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 40mm	S8060-040	FDA UDI	Class II	Unknown
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 32mm	8114-032	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 75mm	8100-075	FDA UDI	Class II	Active
MONOBLOC REAMER 8.0mm	0231-080	FDA UDI	Class I	Active
Fibonacci™ Proximal Posteromedial Tibia Plate, Left, 5 Hole	3085-005	FDA UDI	Class II	Active
AOS TIBIAL NAIL 8mm x 28.5cm	1108-285	FDA UDI	Class II	Active
AOS HUMERAL NAIL 9mm x 20.0cm	S1173-200	FDA UDI	Class II	Unknown
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 34mm	8100-034	FDA UDI	Class II	Active
Perimeter Calcaneal Plate Left, Extra Small	3078-010	FDA UDI	Class II	Active
L-Plate, Left, 3 x 4-Hole	3066-007	FDA UDI	Class II	Active
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 20mm	8031-020	FDA UDI	Class II	Active
AOS END CAP, ANTEGRADE FEMORAL NAIL 0mm	1324	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 34cm	1312-034	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 50mm	8012-500	FDA UDI	Class II	Active
T-Handle, Cannulated, Silicone, Large Hudson	0468	FDA UDI	Class I	Active
Partially Threaded Screw, 4.0mm x 42mm	8086-042	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 11mm x 39cm x 130°	1058-390	FDA UDI	Class II	Active
Aos End Cap, Tibial Nail Compression	S1116	FDA UDI	Class II	Unknown
Cannulated Screwdriver Handle	0426	FDA UDI	Class I	Active
AOS CAPTURED CORTICAL SCREW, FULLY THREADED 6.5mm x 30mm	8059-030	FDA UDI	Class II	Active
AOS Cannulated Drill, Small Hudson, 5.0mm	0243	FDA UDI	Class I	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 40cm	1312-040	FDA UDI	Class II	Active
LAG SCREW, 25mm THREAD LENGTH, Ø10.5mm x 140mm	1045-140	FDA UDI	Class II	Active
AOS CANCELLOUS LOCKING SCREW, PARTIAL THREAD 4.0mm x 48mm	8028-048	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 42cm	1315-042	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 20mm THREAD 7.0mm x 130mm	8040-130	FDA UDI	Class II	Active
AOS MODULAR NAIL 9.0mm x 46cm	1009-460	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 100mm	8103-100	FDA UDI	Class II	Active
Medial Pilon Plate, Right, Short, 13-Hole	3032-013	FDA UDI	Class II	Active
Clavicle System Case	9911	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 45cm x 125°	S1023-455	FDA UDI	Class II	Unknown
AOS CANCELLOUS LOCKING SCREW 4.0mm x 56mm	8023-056	FDA UDI	Class II	Active
AOS CLAVICLE INTRAMEDULLARY DEVICE 3.5mm x 90mm	1300-090	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 14mm x 28cm	S1318-028	FDA UDI	Class II	Unknown
ES™ RETROGRADE FEMORAL NAIL 11mm x 40cm	1391-040	FDA UDI	Class II	Active
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 46mm	8124-046	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø11mm x 45cm x 125°	1023-450	FDA UDI	Class II	Active
AOS CANCELLOUS SCREW 5.0mm x 37.5mm	S8022-037	FDA UDI	Class II	Unknown
Saxena Retractor	0915	FDA UDI	Class I	Active
AOS CALIBRATED STEP DRILL, AO STYLE 3.5/2.5mm x 130mm	0254	FDA UDI	Class I	Active
Radiolucent Targeting Arm, Trochanteric Nail 130°	1268	FDA UDI	Class I	Active
AOS TIBIAL NAIL 12mm x 30.0cm	S1112-300	FDA UDI	Class II	Unknown
Pin Cap, Ao Style	1426-000	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL 10mm x 17cm x 125°	1030-170	FDA UDI	Class II	Active
95° Proximal Humeral Plate 5 Hole	3016-005	FDA UDI	Class II	Active
AOS HUMERAL NAIL 9mm x 27.5cm	S1173-275	FDA UDI	Class II	Unknown
AOS CORTICAL SCREW 5.0mm x 95mm	8000-095	FDA UDI	Class II	Active
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 16mm	8031-016	FDA UDI	Class II	Active
Forceps Lobster Claw, Serrated	0819	FDA UDI	Class I	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 40mm	8060-040	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.