Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Advanced Orthopaedic Solutions, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
64 daysmedian FDA review time
208 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System – AOS Proximal | Advanced Orthopaedic Solutions, Inc. | 2020-10-26 | 56 | 0 |
| K202099 | AOS Galileo™ Trochanteric Nail System | Advanced Orthopaedic Solutions, Inc. | 2020-08-28 | 30 | 0 |
| K191598 | AOS ES Retrograde Femoral Nail | Advanced Orthopaedic Solutions, Inc. | 2019-07-18 | 31 | 0 |
| K160409 | AOS Anterolateral Proximal Humeral Plate | Advanced Orthopaedic Solutions, Inc. | 2016-03-15 | 28 | 0 |
| K143204 | AOS Clavicle Intramedullary Device | Advanced Orthopaedic Solutions, Inc. | 2015-06-03 | 208 | 0 |
| K141912 | AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SM | Advanced Orthopaedic Solutions, Inc. | 2014-10-29 | 106 | 0 |
| K141228 | AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW | Advanced Orthopaedic Solutions, Inc. | 2014-07-08 | 57 | 0 |
| K133081 | TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, | Advanced Orthopaedic Solutions, Inc. | 2013-12-31 | 92 | 0 |
| K132005 | RETROGRADE FEMORAL NAIL | Advanced Orthopaedic Solutions, Inc. | 2013-09-10 | 71 | 0 |
| K123569 | ANTEGRADE FEMORAL NAIL | Advanced Orthopaedic Solutions, Inc. | 2013-05-24 | 185 | 0 |
| K130625 | 12MM AND 13MM TIBIAL NAILS | Advanced Orthopaedic Solutions, Inc. | 2013-03-28 | 20 | 0 |
| K120148 | AOS SOLID LOCKING LAG SCREW, AOS TELESCOPING LAG SCREW | Advanced Orthopaedic Solutions, Inc. | 2012-10-02 | 258 | 0 |
| K122623 | SHORT LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT MODEL | Advanced Orthopaedic Solutions, Inc. | 2012-09-26 | 29 | 0 |
| K103513 | LATERAL SUPERIOR CLAVICLE PLATE, LEFT AND RIGHT; MIDSHAFT SU | Advanced Orthopaedic Solutions, Inc. | 2011-10-24 | 328 | 0 |
| K103533 | ES TROCHANTERIC NAIL, LEFT AND RIGHT, 10MM | Advanced Orthopaedic Solutions, Inc. | 2011-01-19 | 49 | 0 |
| K090478 | AOS PROXIMAL HUMERAL NAIL | Advanced Orthopaedic Solutions, Inc. | 2009-03-26 | 30 | 0 |
| K080590 | AOS PROXIMAL HUMERAL PLATE | Advanced Orthopaedic Solutions, Inc. | 2008-05-06 | 64 | 0 |
| K080408 | EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-10 | Advanced Orthopaedic Solutions, Inc. | 2008-04-25 | 71 | 0 |
| K070444 | AOS TIBIAL NAIL | Advanced Orthopaedic Solutions, Inc. | 2007-06-14 | 119 | 0 |
| K050241 | AOS HUMERAL NAIL | Advanced Orthopaedic Solutions, Inc. | 2005-03-14 | 40 | 0 |
| K021008 | ADVANCED ORTHOPAEDIC SOLUTIONS TROCHANTERIC NAIL | Advanced Orthopaedic Solutions, Inc. | 2002-06-20 | 84 | 12 |
| K014185 | AOS CANNULATED BONE SCREW SYSTEM | Advanced Orthopaedic Solutions, Inc. | 2002-02-13 | 55 | 0 |
| K012190 | AOS MODULAR FEMORAL NAIL | Advanced Orthopaedic Solutions, Inc. | 2001-09-24 | 73 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda