Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Theken Companies, LLC with 5 510(k) clearances and 1 device recall. The most recent is a device recall dated Sep 11, 2025: iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipol….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 11, 2025 | iNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head Assembly, Size 38mm 10-22-0040 Bipolar HeadClass II · Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have po | Device recalls |
| Sep 30, 2022 | Mg-PSZ Ceramic Femoral HeadK220336 · LPH | 510(k) clearances |
| Sep 17, 2019 | iNSitu Bipolar Hip SystemK191297 · KWY | 510(k) clearances |
| Aug 30, 2019 | iNSitu Total Hip SystemK192071 · LPH | 510(k) clearances |
| Sep 21, 2017 | iNSitu Total Hip SystemK172501 · LPH | 510(k) clearances |
| Oct 14, 2016 | iNSitu Total Hip SystemK161184 · LPH | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
