Balanced Knee Revision System - Offset Junction Box
FDA 510(k) K180743 · Ortho Development Corporation
510(k) numberK180743
Submission
- Device name
- Balanced Knee Revision System - Offset Junction Box
- Applicant
- Ortho Development Corporation
Draper, UT, US - Received
- March 22, 2018
- Decision date
- June 20, 2018
- 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 |
|---|---|---|
| K253161 | Balanced Knee System TriMax Porous Femoral ComponentsMBH · Traditional | 12/19/2025SE |
| K251052 | Trivicta® Hip StemMEH · Traditional | 05/22/2025SE |
| K242984 | BKS Revision SystemJWH · Special | 10/25/2024SE |
| K242833 | Legend® Acetabular ShellLPH · Special | 10/11/2024SE |
| K233758 | Trivicta Hip StemMEH · Traditional | 03/08/2024SE |
| K233093 | Balanced Knee® System TriMax PS Plus Tibial InsertJWH · Special | 10/25/2023SE |
| K211086 | The Progen Trochanteric Nail SystemHSB · Traditional | 12/21/2021SE |
| K211471 | Balanced Knee System UniHSX · Traditional | 12/16/2021SE |
| K203023 | Pisces Spinal SystemNKB · Traditional | 07/14/2021SE |
| K200281 | The Gecko Spinal SystemOWI · Traditional | 03/31/2020SE |
Questions and answers
When was Balanced Knee Revision System - Offset Junction Box cleared by the FDA?
Balanced Knee Revision System - Offset Junction Box (K180743) received a 510(k) decision of Substantially Equivalent on June 20, 2018, 90 days after the submission was received.
What is the product code of K180743?
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.