510(k) · Cleared
ClearedADVANCE Porous Coated Spiked Tibial Base
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Microport Orthopedics, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jan 21, 2015 as substantially equivalent to K043083 (Wrightmedicaltechnologyinc, 2005) after a 58-day review. Its family tree reaches back 1 generation to 2005. 9 later devices descend from it.
- Decided
- Jan 21, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043083 (2005). 9 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK043083 Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular…Wrightmedicaltechnologyinc · 2005
- This deviceK143366 ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015
- Descendant · cites it directly · 8 of its ownK152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015
- Descendant · 2 generations on · 7 of its ownK162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block…Microport Orthopedics, Inc. · 2017
- Descendant · 3 generations on · 3 of its ownK171389 EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017
- Descendant · 2 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK253728 EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015 · cites it directly8descendants
- K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Microport Orthopedics, Inc. · 2017 · 2 generations on7descendants
- K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017 · 3 generations on3descendants
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 2 generations on1descendant
- K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043083 | Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel | Wrightmedicaltechnologyinc | 2005 | — |
| 0 (this device) | K143366 | ADVANCE Porous Coated Spiked Tibial Base | Microport Orthopedics, Inc. | 2015 | — |
| +1 | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels… | Microport Orthopedics, Inc. | 2015 | — |
| +2 | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment… | Microport Orthopedics, Inc. | 2017 | — |
| +3 | K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | 2017 | — |
| +2 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +2 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System | Microport Orthopedics, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MBH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K043083 | Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular KeelSummary page 4…ce: ADVANCE® HA Coated Spiked Tibial Base and HA Coated Modular Keel (K043083) Reference Device: ADVANCE® II Porous Coated Modular Titanium Tibial Component… | 2005 |
| † | K061223 | Advance Total Knee System | 2006 |
| † | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | 2014 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 4 | — |
What is it indicated for?
The ADVANCE® Porous Coated Spiked Tibial Base is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:
1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable
using other techniques.
The ADVANCE® Porous Coated Spiked Tibial Base is for uncemented use only.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K143366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143366: ADVANCE Porous Coated Spiked Tibial Base.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143366
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026