Corin BiPolar-i
FDA 510(k) K183114 · Corin U.S.A. Limited
510(k) numberK183114
Submission
- Device name
- Corin BiPolar-i
- Applicant
- Corin U.S.A. Limited
Tampa, FL, US - Received
- November 9, 2018
- Decision date
- June 5, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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| K223441 | SpaceFlex Acetabular CupKWY · Traditional | G21, S.R.L. | 03/23/2023SE |
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| K220492 | COPAL exchange G hip spacerKWY · Special | Heraeus Medical GmbH | 03/23/2022SE |
| K200709 | Kyocera Bipolar Hip SystemKWY · Special | Kyocera Medical Technologies, Inc. | 04/17/2020SE |
| K192236 | Fitmore Hip StemKWY · Special | Zimmer GmbH | 11/05/2019SE |
| K191016 | COPAL exchange G Hip and Knee SpacersKWY · Traditional | Heraeus Medical GmbH | 11/01/2019SE |
| K191297 | iNSitu Bipolar Hip SystemKWY · Traditional | Theken Companies, LLC | 09/17/2019SE |
More from Theken Companies, LLC
| 510(k) | Device | Decision |
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| K242744 | Trinity EVO Acetabular ShellLPH · Traditional | 06/05/2025SE |
| K241808 | ApolloHipX (THR.SS.0001)LLZ · Traditional | 01/07/2025SE |
| K241472 | Icona Hip StemMEH · Traditional | 10/03/2024SE |
| K241570 | Unity Total Knee SystemJWH · Traditional | 09/23/2024SE |
| K240875 | Unity Knee PS-C Tibial InsertJWH · Traditional | 06/26/2024SE |
| K231172 | ApolloKneeOLO · Traditional | 07/26/2023SE |
| K212069 | Corin MetaFix Hip StemLZO · Traditional | 04/07/2022SE |
| K191831 | MobiliT CupLZO · Traditional | 01/16/2020SE |
| K191374 | Revival Modular Hip StemLZO · Traditional | 07/22/2019SE |
| K183533 | Unity Total Knee SystemJWH · Traditional | 06/04/2019SE |
Questions and answers
When was Corin BiPolar-i cleared by the FDA?
Corin BiPolar-i (K183114) received a 510(k) decision of Substantially Equivalent on June 5, 2019, 208 days after the submission was received.
What is the product code of K183114?
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.