EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; A
FDA 510(k) K240043 · Microport Orthopedics, Inc.
510(k) numberK240043
Submission
- Device name
- EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; A
- Applicant
- Microport Orthopedics, Inc.
Arlington, TN, US - Received
- January 5, 2024
- Decision date
- April 1, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3510
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KRO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemKRO · Traditional | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 08/06/2026SE |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella…KRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 12/15/2025SE |
| K252303 | Stem Extension Line (USTAR II System)KRO · Special | United Orthopedic Corporation | 08/22/2025SE |
| K251665 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 07/25/2025SE |
| K242871 | ATTUNE Revision Hinge KneeKRO · Traditional | Depuy Ireland UC | 11/21/2024SE |
| K233980 | ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System…KRO · Traditional | Depuy Ireland UC | 03/21/2024SE |
| K230563 | EVOLUTION® Hinge Knee SystemKRO · Traditional | Microport Orthopedics, Inc. | 09/27/2023SE |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3®KRO · Traditional | Stryker | 05/19/2023SE |
| K223069 | Modular Rotating Hinge Knee Systems and Compatible ComponentsKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 04/21/2023SE |
| K223528 | Triathlon® Hinge Knee SystemKRO · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 01/20/2023SE |
More from Howmedica Osteonics Corp., Dba Stryker Orthopaedics
| 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 |
| K233507 | EVOLUTION® Tibial ConesMBH · Traditional | 01/18/2024SE |
| K231947 | EVOLUTION® Cement KeelJWH · Traditional | 10/31/2023SE |
| 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® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; A cleared by the FDA?
EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; A (K240043) received a 510(k) decision of Substantially Equivalent on April 1, 2024, 87 days after the submission was received.
What is the product code of K240043?
The FDA product code is KRO – Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer, a Class II (moderate risk) device regulated under 21 CFR 888.3510.