Rx Knee System
FDA 510(k) K240683 · Signature Orthopaedics Pty, Ltd.
510(k) numberK240683
Submission
- Device name
- Rx Knee System
- Applicant
- Signature Orthopaedics Pty, Ltd.
Lane Cove West, AU - Received
- March 12, 2024
- Decision date
- September 11, 2024
- 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 |
|---|---|---|
| K252824 | Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral HeadJDI · Traditional | 03/12/2026SE |
| K253239 | Active-V Total Knee System; World Total Knee SystemMBH · Traditional | 12/23/2025SE |
| K251771 | Cambridge Partial KneeHSX · Traditional | 12/16/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | 08/07/2025SE |
| K242674 | Freedom Posterior Cervical ScrewsNKG · Traditional | 05/13/2025SE |
| K242477 | Shoulder Soft Tissue AnchorsMBI · Traditional | 05/12/2025SE |
| K243043 | Origin Cemented Hip StemLZO · Traditional | 05/02/2025SE |
| K243029 | Origin TT StemLZO · Traditional | 03/11/2025SE |
| K243162 | World LinerMEH · Special | 11/25/2024SE |
| K241690 | Logical Liner; World Liner; World Knee PatellaMEH · Special | 08/01/2024SE |
Questions and answers
When was Rx Knee System cleared by the FDA?
Rx Knee System (K240683) received a 510(k) decision of Substantially Equivalent on September 11, 2024, 183 days after the submission was received.
What is the product code of K240683?
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.