EVOLUTION® Cement Keel
FDA 510(k) K231947 · Microport Orthopedics, Inc.
510(k) numberK231947
Submission
- Device name
- EVOLUTION® Cement Keel
- Applicant
- Microport Orthopedics, Inc.
Arlington, TN, US - Received
- June 30, 2023
- Decision date
- October 31, 2023
- 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 |
|---|---|---|
| K253728 | EVOLUTION® AM BIOFOAM® Tibial SystemMBH · Traditional | 08/21/2026SE |
| K250444 | NEXUS® Hip StemLZO · Traditional | 05/15/2025SE |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueJWH · Traditional | 02/18/2025SE |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO HipsLPH · Traditional | 04/18/2024SE |
| K240452 | Ceramic Femoral HeadLZO · Traditional | 04/12/2024SE |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral…KRO · Traditional | 04/01/2024SE |
| K233507 | EVOLUTION® Tibial ConesMBH · Traditional | 01/18/2024SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | 09/27/2023SE |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee InstrumentsMBH · Special | 01/05/2022SE |
| K213816 | MPO Hip InstrumentsJDI · Special | 01/05/2022SE |
Questions and answers
When was EVOLUTION® Cement Keel cleared by the FDA?
EVOLUTION® Cement Keel (K231947) received a 510(k) decision of Substantially Equivalent on October 31, 2023, 123 days after the submission was received.
What is the product code of K231947?
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.