510(k) · Cleared
Recalled · Class I · 2016Advance Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Aug 18, 2006 after a 108-day review. The FDA summary names its predicate without a number. 1 of the 11 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled 13 times, including 11 Class I recalls.
- Decided
- Aug 18, 2006
- Review
- 108 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 13 (11 Class I)
- Predicates
- 0
10 later devices descend from it, 5 citing it directly. 1 of the 11 devices in this family, counting this one, has a Class I recall.
- This deviceK061223 Advance Total Knee SystemWrightmedicaltechnologyinc · 2006
- Descendant · cites it directly · 5 of its ownK140735 Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · Recalled
- Descendant · cites it directly · 2 of its ownK122218 Advance Total Knee System-PatellaWrightmedicaltechnologyinc · 2013
- Descendant · cites it directly · 2 of its ownK093405 Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2010
- Descendant · 2 generations on · 1 of its ownK243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation…Microport Orthopedics, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK103598 Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2011
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K140735Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS InsertsMicroport Orthopedics, Inc. · 2014 · cites it directly5descendants
- K122218Advance Total Knee System-PatellaWrightmedicaltechnologyinc · 2013 · cites it directly2descendants
- K093405Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2010 · cites it directly2descendants
- K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueMicroport Orthopedics, Inc. · 2025 · 2 generations on1descendant
- K103598Prophecy Pre-Operative Navigation Alignment GuidesWrightmedicaltechnologyinc · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K061223 | Advance Total Knee System | Wrightmedicaltechnologyinc | 2006 | — |
| +1 | K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | Microport Orthopedics, Inc. | 2014 | 1 |
| +1 | K122218 | Advance Total Knee System-Patella | Wrightmedicaltechnologyinc | 2013 | — |
| +1 | K093405 | Prophecy Pre-Operative Navigation Alignment Guides | Wrightmedicaltechnologyinc | 2010 | — |
| +2 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and… | Microport Orthopedics, Inc. | 2025 | — |
| +2 | K103598 | Prophecy Pre-Operative Navigation Alignment Guides | Wrightmedicaltechnologyinc | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2022 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | — | ADVANCE Total Knee System Named without a submission number |
What descends from it? (10)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140735 | Evolution MP CS/CR Porous Femur/Evolution Adaptive CS and PS Inserts | 2014 | 5 |
| K122218 | Advance Total Knee System-Patella | 2013 | 2 |
| K093405 | Prophecy Pre-Operative Navigation Alignment Guides | 2010 | 2 |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | 2016 | 0 |
| K152631 | MPO Total Knee Systems MR Labeling | 2016 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 21, 2016 | Class I | Z-2701-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2696-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2703-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2698-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2702-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2695-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2697-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2694-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2699-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2693-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Jun 21, 2016 | Class I | Z-2700-2016 | Use error | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. |
| Sep 22, 2009 | Not classified | Z-0493-2010 | Process control | Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an… |
| Sep 22, 2009 | Not classified | Z-0492-2010 | Process control | Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an… |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K140735 (Microport Orthopedics, Inc., 2014) has gone furthest, with 5 descendants of its own.
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.
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® Total Knee System is 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® Total Knee System components are for use without bone cement and are single use devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061223: Advance Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061223
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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