Advanced Orthopaedic Solutions, Inc.
San Pedro, CA, US
Advanced Orthopaedic Solutions, Inc. appears in FDA device records in San Pedro, CA. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 12 recalls for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Advanced Orthopaedic Solutions, Inc. between 2001 and 2020. The busiest year on record is 2013, with 4. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 1 |
| 2002 | 2 |
| 2005 | 1 |
| 2007 | 1 |
| 2008 | 2 |
| 2009 | 1 |
| 2011 | 2 |
| 2012 | 2 |
| 2013 | 4 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System | HRS | Substantially Equivalent | |
| K202099 | AOS Galileo™ Trochanteric Nail System | HSB | Substantially Equivalent | |
| K191598 | AOS ES Retrograde Femoral Nail | HSB | Substantially Equivalent | |
| K182466 | AOS Calcaneal Plating System | HRS | Substantially Equivalent | |
| K160409 | AOS Anterolateral Proximal Humeral Plate | KTW | Substantially Equivalent | |
| K143204 | AOS Clavicle Intramedullary Device | HSB | Substantially Equivalent | |
| K141912 | AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON | KTT | Substantially Equivalent | |
| K141228 | AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW | HSB | Substantially Equivalent | |
| K133081 | TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N | HSB | Substantially Equivalent | |
| K132005 | RETROGRADE FEMORAL NAIL | HSB | Substantially Equivalent | |
| K123569 | ANTEGRADE FEMORAL NAIL | HSB | Substantially Equivalent | |
| K130625 | 12MM AND 13MM TIBIAL NAILS | HSB | Substantially Equivalent | |
| K120148 | AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW | HSB | Substantially Equivalent | |
| K122623 | SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL 3017-000 (LEFT) AND 3018-000 (RIGHT); 6 HOLE MEDIUM MIDSHAFT | HRS | Substantially Equivalent | |
| K103513 | LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; ANTERIOR CLAVICLE PLA | HRS | Substantially Equivalent | |
| K103533 | ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM | HSB | Substantially Equivalent | |
| K090478 | AOS PROXIMAL HUMERAL NAIL | HSB | Substantially Equivalent | |
| K080590 | AOS PROXIMAL HUMERAL PLATE | KTW | Substantially Equivalent | |
| K080408 | EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD | KTT | Substantially Equivalent | |
| K070444 | AOS TIBIAL NAIL | HSB | Substantially Equivalent | |
| K050241 | AOS HUMERAL NAIL | HSB | Substantially Equivalent | |
| K021008 | ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL | HSB | Substantially Equivalent | |
| K014185 | AOS CANNULATED BONE SCREW SYSTEM | HWC | Substantially Equivalent | |
| K012190 | AOS MODULAR FEMORAL NAIL | HSB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1192-2010 | AOS Trochanteric Nail, 12mm x 20cm x 135, Product Part Number: 1043-200. | 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. | Terminated | ||
| Z-1191-2010 | AOS Trochanteric Nail, 10mm x 20cm x 135, Product Part Number: 1042-200. | 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. | Terminated | ||
| Z-1190-2010 | AOS Trochanteric Nail, 12mm x 20cm x 130, Product Part Number: 1041-200. | 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. | Terminated | ||
| Z-1189-2010 | AOS Trochanteric Nail, 12mm x 17cm x 130, Product Part Number: 1041-170. | 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. | Terminated | ||
| Z-1188-2010 | AOS Trochanteric Nail, 10mm x 20cm x 130, Product Part Number: 1040-200. | 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. | Terminated | ||
| Z-1187-2010 | AOS Trochanteric Nail, 10mm x 17cm x 130, Product Part Number: 1040-170 | 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. | Terminated | ||
| Z-1186-2010 | AOS Trochanteric Nail, 11mm x 20cm x 135, Product Part Number: 1038-200. | 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. | Terminated | ||
| Z-118-2010 | AOS Trochanteric Nail, 13mm x 20cm x 130, Product Part Number: 1037-200. | 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. | Terminated | ||
| Z-1184-2010 | AOS Trochanteric Nail, 11mm x 20cm x 130, Product Part Number: 1036-200. | 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. | Terminated | ||
| Z-1183-2010 | AOS Trochanteric Nail, 11mm x 17cm x 130, Product Part Number: 1036-170. | 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. | Terminated | ||
| Z-1182-2010 | AOS Trochanteric Nail, 9mm x 20cm x 130, Product Part Number: 1034-200. | 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. | Terminated | ||
| Z-1181-2010 | AOS Trochanteric Nail, 9mm x 17cm x 130, Product Part Number: 1034-170. | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain