Theken Companies: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Theken Companies” (first 2022, latest 2022), across 1 product code in 1 review panel. Median 510(k) review time under this name: 235 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 |
|---|---|---|
| 2022 | 1 | 235 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Theken Companies took a median 235 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 156 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 1 | 1 |
Review panels
- Orthopedic (1)
Most recent Theken Companies 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220336 | Mg-PSZ Ceramic Femoral Head | LPH | 2022-09-30 | 235 |
Recalls
openFDA lists no recalls under a recalling firm named Theken Companies.
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.
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.
- Theken Spine, LLC (23 510(k)s)
- Theken Surgical,Llc (6 510(k)s)
- Theken Companies, LLC (4 510(k)s)
- Theken Surgical (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Theken Companies?
FDA lists 1 510(k) clearance under the applicant name “Theken Companies” (first 2022, latest 2022), across 1 product code 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 Theken Companies?
The median time from FDA receipt to decision across 510(k)s cleared under the name Theken Companies is 235 days.
Which FDA product codes appear under Theken Companies?
The most frequent FDA product codes under this applicant name are LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, 1).
Next steps
- See all 1 Theken Companies clearances with predicates and recalls
- Run predicate analysis for product code LPH, Theken Companies'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.