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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 7 of 63

Device	Model / Reference	Registries	Class	Status
AOS TROCHANTERIC NAIL, LEFT 10mm x 42cm x 130°	S1050-420	FDA UDI	Class II	Unknown
AOS ANTEGRADE FEMORAL NAIL, LEFT 14mmx 48cm	S1318-048	FDA UDI	Class II	Unknown
AOS CANNULATED DRILL 3.5mm x 200mm	0276	FDA UDI	Class I	Active
AOS ANTI-ROTATION SCREW 5.0mm x 55mm	8021-055	FDA UDI	Class II	Active
Lateral Distal Fibula Plate, Left, Long, 15-Hole	3051-015	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 42.5mm	8002-042	FDA UDI	Class II	Active
Oblique T-Plate, Right, 3 x 5-Hole	3065-008	FDA UDI	Class II	Active
AOS Drill, AO Style, 4.0mm x 165mm	0210-200	FDA UDI	Class I	Active
Radiolucent Targeting Arm, Calcaneal Plate, Left, Large	4906-060	FDA UDI	Class II	Active
AOS CORTICAL SCREW, LOW PROFILE 3.5mm x 18mm	8031-018	FDA UDI	Class II	Active
Aos Three-Pin Center Clamp, Aos Small External Fixation Multi-Pin Clamp	1409	FDA UDI	Class II	Active
King Tong Forceps	0916-000	FDA UDI	Class II	Active
Universal Targeting Module	1202	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 11mm x 48cm x 125°	S1022-485	FDA UDI	Class II	Unknown
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 28mm	8081-028	FDA UDI	Class II	Active
CARBON FIBER ROD, Ø5.0mm x 250mm	1181-250	FDA UDI	Class II	Active
Ball Spike	0817-000	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 65mm	8041-065	FDA UDI	Class II	Active
Lite Straight Plate, 19-Hole	3061-919	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 30.0mm	8002-030	FDA UDI	Class II	Active
MONOBLOC REAMER 9.0mm	0231-090	FDA UDI	Class I	Active
AOS ES™ TROCHANTERIC NAIL, RIGHT 11mm x 39cm x 130°	S1059-395	FDA UDI	Class II	Unknown
Impactor Pad Humeral Nail	0808-100	FDA UDI	Class I	Active
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 56mm	8124-056	FDA UDI	Class II	Active
Cortical Screw, 5.0mm x 85mm	8000-085	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 26mm	8114-026	FDA UDI	Class II	Active
Non-Locking Screw, 3.5mm x 60mm	8084-060	FDA UDI	Class II	Active
CORTICAL SCREW DOUBLE LEAD LOCKING HEAD 3.5mm x 34mm	8114-034	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 50mm	8061-050	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, Ø13mm x 17cm x 130°	1037-170	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 105mm	S8060-105	FDA UDI	Class II	Unknown
AOS SOLID LOCKING LAG SCREW 10.5mm x 140mm	1094-140	FDA UDI	Class II	Active
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 38mm	8124-038	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 30cm x 130°	S1068-305	FDA UDI	Class II	Unknown
ES™ TROCHANTERIC NAIL RIGHT, 12.5mm x 42cm x 125° PURPLE	1191-425	FDA UDI	Class II	Active
Non-Locking Screw, 3.5mm x 36mm	8084-036	FDA UDI	Class II	Active
Driver Locking Collet Retrograde Femoral Nail	1285	FDA UDI	Class I	Active
GALILEO® TROCHANTERIC NAIL, RIGHT, Ø10mm x 30cm x 125°	1021-300	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 13mm x 34cm	S1317-034	FDA UDI	Class II	Unknown
Sheath External Fixation	0611	FDA UDI	Class I	Active
AOS CANNULATED BLOCKING SCREW 5.0mm x 40mm	S8045-040	FDA UDI	Class II	Unknown
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 28mm	8103-028	FDA UDI	Class II	Active
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 30cm x 130°	1050-300	FDA UDI	Class II	Active
Non-Locking Screw, 3.5mm x 40mm	8084-040	FDA UDI	Class II	Active
AOS TIBIAL NAIL 12mm x 40.5cm	1112-405	FDA UDI	Class II	Active
AOS HUMERAL NAIL 8mm x 32.5cm	S1172-325	FDA UDI	Class II	Unknown
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 48mm	8100-048	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 32cm	1312-032	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 65mm	8100-065	FDA UDI	Class II	Active
Fibonacci™ Proximal Lateral Tibia Plate, Right, 3 Hole	3082-003	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.