FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
K Number: K170288
·
Decision Jun 15, 2017
Classifications
1
FEI Numbers
219
Registration Numbers
219
Same Product Code
142
Applicant Total
37
Review Days
136
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Basic Information
- Device Name
- BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
- K Number
- K170288
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3565
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microport Orthopedics, Inc.
- Date Received
- January 30, 2017
- Decision Date
- June 15, 2017
- Product Code
- MBH
- 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 |
|---|---|---|---|
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, 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 |