Mobio Total Knee System
FDA 510(k) K202429 · B-One Ortho, Corp.
510(k) numberK202429
Submission
- Device name
- Mobio Total Knee System
- Applicant
- B-One Ortho, Corp.
Cedar Knolls, NJ, US - Received
- August 25, 2020
- Decision date
- October 23, 2020
- 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 |
|---|---|---|
| K262341 | b-ONE® Mobio Total Knee System Revision Cemented Tibial Augments, Stem Extensions and…JWH · Traditional | 09/08/2026SE |
| K253357 | b-ONE® Bipolar HeadKWY · Traditional | 04/13/2026SE |
| K240528 | b-ONE® Total Hip SystemLZO · Traditional | 11/15/2024SE |
| K222431 | b-ONER MOBIO Total Knee SystemJWH · Traditional | 10/06/2022SE |
| K213673 | b-ONE MOBIO Total Knee SystemJWH · Traditional | 01/21/2022SE |
| K212912 | OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture…MAI · Traditional | 11/04/2021SE |
| K210483 | MOBIO Total Knee SystemJWH · Traditional | 04/21/2021SE |
| K202768 | KOSMO Femoral StemLZO · Traditional | 04/01/2021SE |
| K182705 | Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsLZO · Traditional | 02/14/2019SE |
| K183025 | MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total…JWH · Traditional | 01/28/2019SE |
Questions and answers
When was Mobio Total Knee System cleared by the FDA?
Mobio Total Knee System (K202429) received a 510(k) decision of Substantially Equivalent on October 23, 2020, 59 days after the submission was received.
What is the product code of K202429?
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.