Theken Companies, LLC
United Statesfrom the FDA registration address FDA establishment FEI 3002498892
- Devices
- 6
- Registrations
- FDA
- FDA recalls
- 11 ongoing
What Theken Companies, LLC makes
THEKEN COMPANIES, LLC manufactures hip replacement systems, including the iNSitu Total Hip System and iNSitu Bipolar Hip System.
These devices are Class II and listed in the FDA 510(k) registry. The company is based in the US.
Catalogue
iNSitu Total Hip System Ref K191936
Regimes: 510(k) Registry: 510(k)iNSitu Total Hip System Ref K161184
Regimes: 510(k) Registry: 510(k)iNSitu Bipolar Hip System Ref K191297
Regimes: 510(k) Registry: 510(k)Mg-PSZ Ceramic Femoral Head Ref K220336
Regimes: 510(k) Registry: 510(k)iNSitu Total Hip System Ref K192071
Regimes: 510(k) Registry: 510(k)iNSitu Total Hip System Ref K172501
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3002498892
- Address
- 1800 Triplett Blvd, Akron, OH, 44306
FDA recalls
FDA recall records list 1 recall initiated by THEKEN COMPANIES, LLC, initiated on 2025-09-11. By recorded status: 1 ongoing. The reasons filed fall into these groups: sterility or contamination. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 1
- 2026 0
2025
- 11 Sep 2025 Z-0227-2026 Class II Ongoing Downstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile barrier.
Frequently asked questions
How many devices does THEKEN COMPANIES, LLC have in the registry?
The registry currently lists 6 devices for THEKEN COMPANIES, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list THEKEN COMPANIES, LLC's devices?
Among its 6 most recently registered devices, THEKEN COMPANIES, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do THEKEN COMPANIES, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for THEKEN COMPANIES, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for THEKEN COMPANIES, LLC?
FDA recall records list 1 recall initiated by THEKEN COMPANIES, LLC, the most recent initiated on 11 Sep 2025. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from THEKEN COMPANIES, LLC in the registry?
The most recently registered devices listed for THEKEN COMPANIES, LLC include iNSitu Total Hip System, iNSitu Bipolar Hip System and Mg-PSZ Ceramic Femoral Head.