NovoKnee (SteriKnee)
FDA 510(k) K261032 · NovoSource
510(k) numberK261032
Submission
- Device name
- NovoKnee (SteriKnee)
- Applicant
- NovoSource
Morgantown, WV, US - Received
- March 30, 2026
- Decision date
- April 27, 2026
- 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 |
| K253793 | Materialise TKA Guide SystemJWH · Special | Materialise NV | 01/06/2026SE |
More from Materialise NV
| 510(k) | Device | Decision |
|---|---|---|
| K140701 | Novohip Bipolar Head/Novohip Vitamin E Liner/ Bone Screws/ Hole PlugOQG · Traditional | 06/27/2014SE |
| K132158 | Novohip Total Hip SystemLPH · Traditional | 02/21/2014SE |
| K131398 | Novoknee Total Knee SystemJWH · Traditional | 09/16/2013SE |
| K123339 | TK1 Total Knee SystemJWH · Traditional | 04/11/2013SE |
Questions and answers
When was NovoKnee (SteriKnee) cleared by the FDA?
NovoKnee (SteriKnee) (K261032) received a 510(k) decision of Substantially Equivalent on April 27, 2026, 28 days after the submission was received.
What is the product code of K261032?
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.