Thackray USA: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Thackray USA” (first 1986, latest 1988), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 77 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 2 | 2 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
Plus 1 more product codes.
Review panels
- Orthopedic (4)
Most recent Thackray USA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K882890 | WROBLEWSKI SPRING COMPRESSION WIRE SYSTEM | JDQ | 1988-08-08 | 28 |
| K871867 | ELITE MODULAR HIP SYSTEM | JDI | 1988-04-08 | 331 |
| K871852 | COXA ACETABULAR CUP | JDI | 1988-02-18 | 282 |
| K863554 | THACKRAY CRUCIATE SPARING KNEE CS-1 | — | 1986-10-06 | 24 |
| K855166 | THACKRAY TOTAL CONDYLAR KNEES | JWH | 1986-03-13 | 77 |
Recalls
openFDA lists no recalls under a recalling firm named Thackray USA.
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 Thackray USA?
FDA lists 5 510(k) clearances under the applicant name “Thackray USA” (first 1986, latest 1988), across 4 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 Thackray USA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Thackray USA is 77 days.
Which FDA product codes appear under Thackray USA?
The most frequent FDA product codes under this applicant name are JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, 2); JDQ (Cerclage, Fixation, 1); JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, 1).
Next steps
- See all 5 Thackray USA clearances with predicates and recalls
- Run predicate analysis for product code JDI, Thackray USA'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.