Thackray USA: FDA clearances and approvals
Thackray USA has 5 FDA 510(k) clearances (first 1986, latest 1988), across 4 product codes in 1 review panel. Median 510(k) review time: 77 days.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Thackray USA have?
Thackray USA has 5 FDA 510(k) clearances (first 1986, latest 1988), across 4 product codes in 1 review panel.
How long does FDA take to clear Thackray USA's 510(k)s?
The median time from FDA receipt to decision across Thackray USA's cleared 510(k)s is 77 days.
What devices does Thackray USA make?
Its most frequent FDA product codes 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).
Has Thackray USA had device recalls?
openFDA lists no recalls under a recalling firm name matching Thackray USA. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.