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Theken Companies LLC

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0227-2026Class IIiNSitu Bipolar Hip System, Bipolar head implant Part ID Description 10-22-0038 Bipolar Head AsseSeptember 11, 2025

Recent 510(k) Clearances

K-NumberDeviceDate
K220336Mg-PSZ Ceramic Femoral HeadSeptember 30, 2022
K191297iNSitu Bipolar Hip SystemSeptember 17, 2019
K192071iNSitu Total Hip SystemAugust 30, 2019
K172501iNSitu Total Hip SystemSeptember 21, 2017
K161184iNSitu Total Hip SystemOctober 14, 2016