Bencox THR System
FDA 510(k) K211866 · Corentec Co., Ltd.
510(k) numberK211866
Submission
- Device name
- Bencox THR System
- Applicant
- Corentec Co., Ltd.
Cheonan, KR - Received
- June 16, 2021
- Decision date
- July 14, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LPH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253630 | Mpact 3D Metal FoamLPH · Traditional | Medacta International S.A. | 08/28/2026SE |
| K254043 | TRIVANCE Hip StemLPH · Traditional | Globus Medical, Inc. | 08/04/2026SE |
| K261624 | Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained…LPH · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/10/2026SE |
| K243192 | iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi…LPH · Traditional | Nextstep Arthopedix, LLC | 06/05/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | Biomet, Inc. | 05/19/2026SE |
| K252623 | G7® Revision Acetabular SystemLPH · Traditional | Zimmer, Inc. | 02/04/2026SE |
| K251043 | Mpact 3D Metal Implants Extension DMLS TechnologyLPH · Traditional | Medacta International S.A. | 01/28/2026SE |
| K252067 | Velora Acetabular SystemLPH · Traditional | Restor3D, Inc. | 12/05/2025SE |
| K252846 | TaperSet Hip SystemLPH · Special | Shalby Advanced Technologies, Inc. Dba Consensus… | 11/20/2025SE |
| K251833 | EMPOWR Acetabular® Liner ExtensionLPH · Traditional | Encore Medical L.P. | 11/12/2025SE |
More from Encore Medical L.P.
| 510(k) | Device | Decision |
|---|---|---|
| K250889 | EXULT Knee Replacement SystemJWH · Special | 04/17/2025SE |
| K242401 | EXULT Knee Replacement SystemJWH · Special | 09/12/2024SE |
| K242046 | EXULT Knee Replacement SystemJWH · Special | 08/01/2024SE |
| K223828 | BENCOX Delta Option HeadsLZO · Traditional | 03/16/2023SE |
| K223223 | BENCOX Mirabo Z Cup CortiniumLPH · Special | 02/27/2023SE |
| K222278 | LOSPA TKR System Instrumentation, EXULT TKR System InstrumentationJWH · Special | 08/26/2022SE |
| K210614 | BENCOX Mirabo Z Cup CortiniumLPH · Traditional | 05/24/2022SE |
| K220468 | BENCOX Mirabo Cup SystemLPH · Special | 05/18/2022SE |
| K212034 | LOSPA TKR SystemJWH · Traditional | 12/09/2021SE |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - RightJWH · Special | 07/30/2020SE |
Questions and answers
When was Bencox THR System cleared by the FDA?
Bencox THR System (K211866) received a 510(k) decision of Substantially Equivalent on July 14, 2021, 28 days after the submission was received.
What is the product code of K211866?
The FDA product code is LPH – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.