Advanced Orthopaedic Solutions, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under 2 spellings of the applicant name “Advanced Orthopaedic Solutions, Inc.” (first 2001, latest 2020), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 40 days, against 104 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 144 |
| 2013 | 4 | 82 |
| 2014 | 2 | 82 |
| 2015 | 1 | 208 |
| 2016 | 1 | 28 |
| 2017 | 0 | — |
| 2018 | 1 | 50 |
| 2019 | 1 | 31 |
| 2020 | 2 | 43 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Advanced Orthopaedic Solutions, Inc. took a median 40 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 15 | 15 |
| HRS | Plate, Fixation, Bone | 4 | 4 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 | 2 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 2 | 2 |
| HWC | Screw, Fixation, Bone | 1 | 1 |
Review panels
- Orthopedic (24)
Most recent Advanced Orthopaedic Solutions, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202489 | AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System | HRS | 2020-10-26 | 56 |
| K202099 | AOS Galileo Trochanteric Nail System | HSB | 2020-08-28 | 30 |
| K191598 | AOS ES Retrograde Femoral Nail | HSB | 2019-07-18 | 31 |
| K182466 | AOS Calcaneal Plating System | HRS | 2018-10-30 | 50 |
| K160409 | AOS Anterolateral Proximal Humeral Plate | KTW | 2016-03-15 | 28 |
| K143204 | AOS Clavicle Intramedullary Device | HSB | 2015-06-03 | 208 |
| K141912 | AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FIXATION, CARBON FIBER RODS, AOS SMALL BON | KTT | 2014-10-29 | 106 |
| K141228 | AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW | HSB | 2014-07-08 | 57 |
| K133081 | TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEGRADE FEMORAL NAILS, RETROGRADE FEMORAL N | HSB | 2013-12-31 | 92 |
| K132005 | RETROGRADE FEMORAL NAIL | HSB | 2013-09-10 | 71 |
14 earlier clearances. See the full list in Caduvo.
Recalls
12 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-01-14.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Advanced Orthopaedic Solutions, Inc. (23)
- Advanced Orthopaedic Solutions (1)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Advanced Cardiovascular Systems, Inc. (103 510(k)s)
- Advanced Surgical Products, Inc. (64 510(k)s)
- Advanced Technology Laboratories, Inc. (61 510(k)s)
- Advanced Sterilization Products (59 510(k)s)
- Advanced Neuromodulation Systems (25 510(k)s)
- Advanced Medical Solutions, Ltd. (22 510(k)s)
- Advanced Biosearch Assn. (22 510(k)s)
- Advanced Biomedical Methods, Inc. (21 510(k)s)
- Advanced Surgical, Inc. (21 510(k)s)
- Advanced Clinical Diagnostics (19 510(k)s)
- Advanced Instrumentations, Inc. (16 510(k)s)
- Advanced Instruments, Inc. (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Advanced Orthopaedic Solutions, Inc.?
FDA lists 24 510(k) clearances under 2 spellings of the applicant name “Advanced Orthopaedic Solutions, Inc.” (first 2001, latest 2020), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Advanced Orthopaedic Solutions, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Advanced Orthopaedic Solutions, Inc. is 60 days. Since 2017: 40 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Advanced Orthopaedic Solutions, Inc.?
The most frequent FDA product codes under this applicant name are HSB (Rod, Fixation, Intramedullary And Accessories, 15); HRS (Plate, Fixation, Bone, 4); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 2).
Next steps
- See all 24 Advanced Orthopaedic Solutions, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HSB, Advanced Orthopaedic Solutions, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.