EXULT Knee Replacement System
FDA 510(k) K250889 · Corentec Co., Ltd.
510(k) numberK250889
Submission
- Device name
- EXULT Knee Replacement System
- Applicant
- Corentec Co., Ltd.
Chungchongnam-Do, KR - Received
- March 25, 2025
- Decision date
- April 17, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3560
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JWH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260063 | GSPE SpacerJWH · Traditional | The General Hospital Corporation, d/b/a… | 09/11/2026SE |
| K262293 | EVOLUTION MPX Total Knee SystemJWH · Traditional | Suzhou Microport Orthorecon Co., Ltd. | 09/10/2026SE |
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | B-One Ortho, Corp. | 09/08/2026SE |
| K262130 | ATTUNE Revision Knee SystemJWH · Traditional | Depuy Orthopaedics, Inc. | 09/04/2026SE |
| K253961 | SK Knee SystemJWH · Traditional | Just Medical Devices (Tianjin) Co., Ltd. | 09/01/2026SE |
| K261563 | Freedom Total Knee System (E-Poly Tibial Liners)JWH · Traditional | Maxx Orthopedics, Inc. | 08/07/2026SE |
| K262251 | ACTIFY Total Knee System, ACTIFY 3D Total Knee System (ACTIFY MC Tibial Insert)JWH · Special | Globus Medical, Inc. | 07/31/2026SE |
| K261734 | Klassic Infection Spacer SystemJWH · Traditional | Total Joint Orthopedics, Inc. | 07/23/2026SE |
| K261458 | ATTUNE Total Knee System; ATTUNE Cementless Knee SystemJWH · Traditional | DePuy Ireland UC | 06/25/2026SE |
| K261032 | NovoKnee (SteriKnee)JWH · Special | NovoSource | 04/27/2026SE |
More from NovoSource
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K211866 | Bencox THR SystemLPH · Special | 07/14/2021SE |
| K201851 | EXULT Femoral component trial - Left, EXULT Femoral component trial - RightJWH · Special | 07/30/2020SE |
Questions and answers
When was EXULT Knee Replacement System cleared by the FDA?
EXULT Knee Replacement System (K250889) received a 510(k) decision of Substantially Equivalent on April 17, 2025, 23 days after the submission was received.
What is the product code of K250889?
The FDA product code is JWH – Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3560.