Initia Knee System
FDA 510(k) K243295 · Kyocera Medical Technologies, Inc.
510(k) numberK243295
Submission
- Device name
- Initia Knee System
- Applicant
- Kyocera Medical Technologies, Inc.
Redlands, CA, US - Received
- October 18, 2024
- Decision date
- January 13, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | 07/15/2026SE |
| K242928 | Tesera-k SC SystemOVE · Traditional | 04/10/2025SE |
| K242045 | Initia T3 Acetabular Hemispherical Shell SystemLPH · Traditional | 04/10/2025SE |
| K242771 | Tesera-k PL System and Tesera-k XL SystemMAX · Traditional | 03/20/2025SE |
| K243015 | Skyway Anterior Cervical Plate SystemKWQ · Traditional | 11/05/2024SE |
| K232114 | TRIBRID® Unicompartmental Knee SystemHSX · Traditional | 04/04/2024SE |
| K230808 | PEEK SA Anterior Lumbar Interbody Fusion (ALIF) SystemOVD · Special | 04/21/2023SE |
| K223105 | Tesera-K SC SystemOVE · Traditional | 12/22/2022SE |
| K212980 | Tesera-k ALIF SystemOVD · Traditional | 01/07/2022SE |
| K212070 | KMTI S141 Lumbar Interbody Fusion SystemMAX · Special | 08/30/2021SE |
Questions and answers
When was Initia Knee System cleared by the FDA?
Initia Knee System (K243295) received a 510(k) decision of Substantially Equivalent on January 13, 2025, 87 days after the submission was received.
What is the product code of K243295?
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.