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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 31 of 63

Device	Model / Reference	Registries	Class	Status
Screw Sheath	0600-200	FDA UDI	Class I	Active
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 28mm	8124-028	FDA UDI	Class II	Active
AOS THREADED HALF PIN (AO STYLE) 2.0mm x 140mm x 20mm	1412-140	FDA UDI	Class II	Active
AOS CAPTURED CORTICAL SCREW 4.2mm x 95mm	S8002-095	FDA UDI	Class II	Unknown
AOS ES™ TROCHANTERIC NAIL, LEFT 12.5mm x 36cm x 130°	1122-365	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, RIGHT 12.5mm x 36cm x 130°	S1123-360	FDA UDI	Class II	Unknown
AOS CORTICAL SCREW 3.5mm x 45.0mm	S8010-450	FDA UDI	Class II	Unknown
ES™ TROCHANTERIC NAIL, LEFT, Ø11mm x 33cm x 125°	1022-335	FDA UDI	Class II	Active
AP Connection Bolt	1290-100	FDA UDI	Class II	Active
AOS CANNULATED CANCELLOUS SCREW, 36mm THREAD 7.0mm x 125mm	8041-125	FDA UDI	Class II	Active
CORTICAL BONE SCREW 3.5mm x 32mm	8110-032	FDA UDI	Class II	Active
Aos Hex Post Bent	1421	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIAL THREAD 6.0mm x 105mm	8061-105	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 30cm	S1316-030	FDA UDI	Class II	Unknown
Screw Sheath	0600-100	FDA UDI	Class I	Active
L-Plate, Right, 3 x 2-Hole	3067-005	FDA UDI	Class II	Active
Variable Angle Locking Screw, 3.5mm x 26mm	8088-026	FDA UDI	Class II	Active
Lower Extremity Reamer Case	9918-100	FDA UDI	Class II	Active
AOS TIBIAL NAIL 13mm x 31.5cm	1113-315	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 12mm x 30cm	S1315-030	FDA UDI	Class II	Unknown
AOS ANTI-ROTATION SCREW 5.0mm x 80mm	S8021-080	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW 5.0mm x 48mm	S8001-048	FDA UDI	Class II	Unknown
AOS SUPRACONDYLAR FEMORAL NAIL 10mm x 18cm	1344-018	FDA UDI	Class II	Active
CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 54mm	8124-054	FDA UDI	Class II	Active
Tibial Nail Case	9974-000	FDA UDI	Class II	Active
CORTICAL SCREW 3.5mm x 25.0mm	8010-250	FDA UDI	Class II	Active
Lag Screw Inserter, Trochanteric Nail	0463-100	FDA UDI	Class I	Active
AOS RETROGRADE FEMORAL NAIL 10mm x 26cm	1340-026	FDA UDI	Class II	Active
Non-Locking Screw, 3.5mm x 24mm	8084-024	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, FULLY THREADED 6.5mm x 105mm	8065-105	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, RIGHT 11mm x 30cm	1313-030	FDA UDI	Class II	Active
Partially Threaded Screw, 4.0mm x 60mm	8086-060	FDA UDI	Class II	Active
AOS ANTEGRADE FEMORAL NAIL, LEFT 11mm x 28cm	1312-028	FDA UDI	Class II	Active
AOS TROCHANTERIC NAIL, LEFT 12.5mm x 48cm x 130°	1122-480	FDA UDI	Class II	Active
CORTICAL LOCKING SCREW 3.5mm x 38mm	8012-380	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 30mm	8103-030	FDA UDI	Class II	Active
ES™ RETROGRADE FEMORAL NAIL 13mm x 34cm	1393-034	FDA UDI	Class II	Active
GALILEO® CRT²™ LAG SCREW, RIGHT, 10.5mm x 95mm	1092-095	FDA UDI	Class II	Active
Straight Plate, 3-Hole	3061-003	FDA UDI	Class II	Active
Cannulated Headless Compression Screw, 1/2 Threaded, 3.5mm x 90mm	8081-090	FDA UDI	Class II	Active
AOS ES™ TROCHANTERIC NAIL, LEFT 14mm x 48cm x 130°	1068-485	FDA UDI	Class II	Active
WORKHORSE SCREW™, T10, NON-LOCKING, Ø3.5mm x 26mm	8100-026	FDA UDI	Class II	Active
AOS CANCELLOUS LAG SCREW 4.0mm x 14mm	8032-014	FDA UDI	Class II	Active
POWER HEX SCREW DRIVER 5.0mm	0488-200	FDA UDI	Class I	Active
AOS ANTI-ROTATION SCREW 5.0mm x 90mm	S8021-090	FDA UDI	Class II	Unknown
AOS THREADED PIN 3.0mm x 100mm	1162	FDA UDI	Class II	Active
AOS CAPTURED CANCELLOUS SCREW, PARTIALLY THREADED 6.0mm x 35mm	S8061-035	FDA UDI	Class II	Unknown
AOS CAPTURED CORTICAL SCREW 4.2mm x 35mm	S8002-035	FDA UDI	Class II	Unknown
AOS CANCELLOUS LOCKING SCREW, FULLY THREADED 4.0mm x 56mm	8024-056	FDA UDI	Class II	Active
DIAMOND WORKHORSE SCREW™, Ø3.5mm x 80mm	8103-080	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.