iNSitu Bipolar Hip System

FDA 510(k) K191297 · Theken Companies, LLC

Substantially Equivalent

510(k) numberK191297

Submission

Device name
iNSitu Bipolar Hip System
Applicant
Theken Companies, LLC
Akron, OH, US
Received
May 14, 2019
Decision date
September 17, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3390
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code KWY

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K253357b-ONE® Bipolar HeadKWY · Traditional B-One Ortho, Corp.04/13/2026SE
K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)KWY · Traditional Maxx Orthopedics, Inc.08/25/2025SE
K231526CORAIL Cemented Femoral StemKWY · Traditional Depuy Ireland UC12/19/2023SE
K223441SpaceFlex Acetabular CupKWY · Traditional G21, S.R.L.03/23/2023SE
K221794Vario-Cup SystemKWY · Special Waldemar Link GmbH & Co. KG07/20/2022SE
K220492COPAL exchange G hip spacerKWY · Special Heraeus Medical GmbH03/23/2022SE
K200709Kyocera Bipolar Hip SystemKWY · Special Kyocera Medical Technologies, Inc.04/17/2020SE
K192236Fitmore Hip StemKWY · Special Zimmer GmbH11/05/2019SE
K191016COPAL exchange G Hip and Knee SpacersKWY · Traditional Heraeus Medical GmbH11/01/2019SE
K191569Implantcast ic-Bipolar Head SystemKWY · Traditional Implantcast GmbH08/28/2019SE

More from Implantcast GmbH

510(k)DeviceDecision
K220336Mg-PSZ Ceramic Femoral HeadLPH · Special 09/30/2022SE
K192071iNSitu Total Hip SystemLPH · Special 08/30/2019SE
K172501iNSitu Total Hip SystemLPH · Special 09/21/2017SE
K161184iNSitu Total Hip SystemLPH · Traditional 10/14/2016SE

Questions and answers

When was iNSitu Bipolar Hip System cleared by the FDA?

iNSitu Bipolar Hip System (K191297) received a 510(k) decision of Substantially Equivalent on September 17, 2019, 126 days after the submission was received.

What is the product code of K191297?

The FDA product code is KWY – Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3390.