The Progressive Orthopaedic Company, LLC: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “The Progressive Orthopaedic Company, LLC” (first 2015, latest 2019), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 105 days. 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 |
|---|---|---|
| 2015 | 3 | 100 |
| 2016 | 1 | 426 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 105 |
| 2020 | 0 | — |
| 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 The Progressive Orthopaedic Company, LLC took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 3 | 3 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent The Progressive Orthopaedic Company, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K183344 | The Progressive Orthopaedic Company Total Knee System II | JWH | 2019-03-18 | 105 |
| K151424 | The Progressive Orthopaedic Total Hip System | LPH | 2016-07-27 | 426 |
| K150783 | Progressive Orthopaedic Total Knee System | JWH | 2015-06-23 | 90 |
| K142649 | Progressive Orthopedic Total Knee System | JWH | 2015-03-24 | 188 |
| K143314 | Progressive Orthopaedic Total Hip System | LPH | 2015-02-27 | 100 |
Recalls
openFDA lists no recalls under a recalling firm named The Progressive Orthopaedic Company, LLC.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under The Progressive Orthopaedic Company, LLC?
FDA lists 5 510(k) clearances under the applicant name “The Progressive Orthopaedic Company, LLC” (first 2015, latest 2019), across 2 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 The Progressive Orthopaedic Company, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name The Progressive Orthopaedic Company, LLC is 105 days.
Which FDA product codes appear under The Progressive Orthopaedic Company, LLC?
The most frequent FDA product codes under this applicant name are JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 3); LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 2).
Next steps
- See all 5 The Progressive Orthopaedic Company, LLC clearances with predicates and recalls
- Run predicate analysis for product code JWH, The Progressive Orthopaedic Company, LLC'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.