510(k) Report

510(k) · Cleared

Cleared

Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel

K043083510(k) AbbreviatedCleared Apr 18, 2005161-day reviewClass II21 CFR 888.3565

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wrightmedicaltechnologyinc · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer

Cleared on Apr 18, 2005 after a 161-day review. The FDA summary names no predicate by number. 11 later devices descend from it.

Decided
Apr 18, 2005
Review
161 days
Class
Class II
Product code
MBH
Recalls
None
Predicates
0

11 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2015: 2 descendants cleared2016: 1 descendant cleared2022: 1 descendant cleared2018: 1 descendant cleared2025: 1 descendant cleared2017: 2 descendants cleared2026: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared20052010201520202025
  1. This deviceK043083 Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular…Wrightmedicaltechnologyinc · 2005
  2. Descendant · cites it directly · 9 of its ownK143366 ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015
  3. Descendant · 2 generations on · 8 of its ownK152298 EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015
  4. Descendant · 3 generations on · 7 of its ownK162026 EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block…Microport Orthopedics, Inc. · 2017
  5. Descendant · 4 generations on · 3 of its ownK171389 EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017
  6. Descendant · 3 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2015: 22016: 12017: 22018: 12022: 12023: 12024: 12025: 12026: 1
2015high 2 (2015) · low 0 (2019)2026

Most influential descendants

Showing 5 of 11 · See all
  • K143366ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc. · 2015 · cites it directly9descendants
  • K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE…Microport Orthopedics, Inc. · 2015 · 2 generations on8descendants
  • K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION…Microport Orthopedics, Inc. · 2017 · 3 generations on7descendants
  • K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc. · 2017 · 4 generations on3descendants
  • K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K043083Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular KeelWrightmedicaltechnologyinc2005—
+1K143366ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc.2015—
+2K152298EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels…Microport Orthopedics, Inc.2015—
+3K162026EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment…Microport Orthopedics, Inc.2017—
+4K171389EVOLUTION Revision CCK SystemMicroport Orthopedics, Inc.2017—
+3K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and…Microport Orthopedics, Inc.2025—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201520
201610
201720
201810
202210
202310
202410
202510
202610
FIG. 1 — Lineage of K043083, 2005–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K241597 Freedom® Total Knee System - Porous Tibial…score 20.0 · 8 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (11)

See all 11

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K143366ADVANCE Porous Coated Spiked Tibial BaseMicroport Orthopedics, Inc.20159
K152631MPO Total Knee Systems MR LabelingMicroport Orthopedics, Inc.20160

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?

  • Of its descendants, K143366 (Microport Orthopedics, Inc., 2015) has gone furthest, with 9 descendants of its own.

How does its category compare?

All MBH devices

MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBH

8in 2025

2007: 102008: 32009: 32010: 42011: 52012: 52013: 62014: 92015: 82016: 42017: 42018: 62019: 12020: 72021: 62022: 72023: 62024: 102025: 82026 (partial year): 7
2007high 10 (2007) · low 1 (2019)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBH

98in 2025

2007: 59 days median2008: 70 days median2009: 209 days median2010: 84 days median2011: 84 days median2012: 90 days median2013: 138 days median2014: 114 days median2015: 100 days median2016: 74 days median2017: 115 days median2018: 89 days median2020: 112 days median2021: 48 days median2022: 57 days median2023: 94 days median2024: 84 days median2025: 98 days median2026 (partial year): 153 days median
2007high 209 (2009) · low 48 (2021)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MBH

1in 2024

2009: 22011: 152012: 1, 1 Class I2013: 4, 4 Class I2016: 12017: 92018: 12019: 12020: 22023: 22024: 12026 (partial year): 4
2007high 15 (2011) · low 0 (2007)2026

Class I (5 since 2007) Class II/III not classified

Adverse event reports per year · MBH

1,561in 2025

2007: 272008: 212009: 892010: 1212011: 2472012: 3702013: 3082014: 3852015: 9552016: 1,0342017: 1,0072018: 1,1912019: 1,3942020: 1,0892021: 1,5392022: 1,2612023: 1,2632024: 1,4972025: 1,561
2007high 1,561 (2025) · low 21 (2008)2025

MAUDE reports naming product code MBH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071059027
2008370021
20093209289
20104840121
201158415247
20125901 (1)370
201361384 (4)308
201491140385
201581000955
201647411,034
2017411591,007
201868911,191
20191—11,394
2020711221,089
202164801,539
202275701,261
202369421,263
2024108411,497
202589801,561
202671534—

What is it indicated for?

The ADVANCE® HA Coated Components are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1) noninflammatory 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

5) treatment of fractures that are unmanageable using other techniques.

The ADVANCE® HA Coated Components are for use without bone cement and are single use devices.

Indications for use as stated in the FDA summary.

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Recent decisions in MBH

The MBH category page

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  • K261462LANDMARK Total Knee SystemSmith & Nephew, Inc. · 2026
  • K253728EVOLUTION® AM BIOFOAM® Tibial SystemMicroport Orthopedics, Inc. · 2026
  • K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc. · 2026
  • K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc. · 2026

https://510kreport.com/device/K043083 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043083: Advance HA Coated Spiked Tibial Base and Advance HA Coated Modular Keel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043083

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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