FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
K Number: K162026
·
Decision Mar 1, 2017
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
37
Review Days
222
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Basic Information
- Device Name
- EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
- K Number
- K162026
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microport Orthopedics, Inc.
- Date Received
- July 22, 2016
- Decision Date
- March 1, 2017
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Microport Orthopedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250444 | NEXUS® Hip Stem | May 15, 2025 | Substantially Equivalent |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | Feb 18, 2025 | Substantially Equivalent |
| K240452 | Ceramic Femoral Head | Apr 12, 2024 | Substantially Equivalent |
| K240043 | 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; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse | Apr 1, 2024 | Substantially Equivalent |
| K233507 | EVOLUTION® Tibial Cones | Jan 18, 2024 | Substantially Equivalent |
| K231947 | EVOLUTION® Cement Keel | Oct 31, 2023 | Substantially Equivalent |
| K230563 | EVOLUTION® Hinge Knee System | Sep 27, 2023 | Substantially Equivalent |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Jan 5, 2022 | Substantially Equivalent |
| K213816 | MPO Hip Instruments | Jan 5, 2022 | Substantially Equivalent |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | Oct 1, 2021 | Substantially Equivalent |