# Theken Companies, LLC

- Location (FDA's records): Akron, OH
- FDA decisions: 5 (2016–2022): 5 510(k) clearances
- Names in FDA's records: Theken Companies, LLC (4); Theken Companies (1)
- Product codes: LPH (4), KWY (1)
- 510(k) review time since 2016: median 126 days, against 150 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 14 (6 its own); citations of its devices by later devices: 14 (6 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Biopro, Inc.: 4 (https://510kreport.com/company/biopro)
- Consensus Orthopedics, Inc.: 2 (https://510kreport.com/company/consensus-orthopedics)
- Thecken Companies, LLC: 1 (https://510kreport.com/company/thecken-companies)
- Pipeline Orthopedics: 1 (https://510kreport.com/company/pipeline-orthopedics)

## Firms that cite its devices most
- Nextstep Arthopedix, LLC: 3 (https://510kreport.com/company/nextstep-arthopedix)
- Thecken Companies, LLC: 2 (https://510kreport.com/company/thecken-companies)
- Nextstep Arthropedix: 1 (https://510kreport.com/company/nextstep-arthropedix)
- Implantcast GmbH: 1 (https://510kreport.com/company/implantcast)
- Signature Orthopaedics Pty, Ltd.: 1 (https://510kreport.com/company/signature-orthopaedics)

## Its most-cited devices
- K161184: iNSitu Total Hip System (2016), cited by 7
- K172501: iNSitu Total Hip System (2017), cited by 4
- K192071: iNSitu Total Hip System (2019), cited by 2
- K191297: iNSitu Bipolar Hip System (2019), cited by 1

## Recent decisions
- K220336: Mg-PSZ Ceramic Femoral Head (Sep 30, 2022)
- K191297: iNSitu Bipolar Hip System (Sep 17, 2019)
- K192071: iNSitu Total Hip System (Aug 30, 2019)
- K172501: iNSitu Total Hip System (Sep 21, 2017)
- K161184: iNSitu Total Hip System (Oct 14, 2016)

Source page: https://510kreport.com/company/theken-companies