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510(k) K191297

iNSitu Bipolar Hip System by Theken Companies, LLC — Product Code KWY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 2019
Date Received
May 14, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device Class
Class II
Regulation Number
888.3390
Review Panel
OR
Submission Type

Other clearances by Theken Companies, LLC

  • K220336 — Mg-PSZ Ceramic Femoral Head (September 30, 2022)
  • K192071 — iNSitu Total Hip System (August 30, 2019)
  • K172501 — iNSitu Total Hip System (September 21, 2017)
  • K161184 — iNSitu Total Hip System (October 14, 2016)

Other clearances for product code KWY

  • K243634 — Maxx Libertas Bipolar Hip Head (Bipolar Hip) (August 25, 2025)
  • K231526 — CORAIL Cemented Femoral Stem (December 19, 2023)
  • K223441 — SpaceFlex Acetabular Cup (March 23, 2023)
  • K221794 — Vario-Cup System (July 20, 2022)
  • K220492 — COPAL exchange G hip spacer (March 23, 2022)
  • K200709 — Kyocera Bipolar Hip System (April 17, 2020)
  • K192236 — Fitmore Hip Stem (November 5, 2019)
  • K191016 — COPAL exchange G Hip and Knee Spacers (November 1, 2019)
  • K191569 — Implantcast ic-Bipolar Head System (August 28, 2019)
  • K183114 — Corin BiPolar-i (June 5, 2019)