510(k) · Cleared
ClearedSearch Evolution (LC) Total Knee System (Porous Coated)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesculap, Inc. · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Jan 15, 2004 as substantially equivalent to K022672 (Aesculap, Inc., 2002) and 3 other predicates after a 191-day review. Its family tree reaches back 4 generations to 1992. 80 later devices descend from it.
- Decided
- Jan 15, 2004
- Review
- 191 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K915192 (1992). 12 ancestors in all. 80 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
- 3 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
- 2 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
- 1 generation backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
- This deviceK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
- Descendant · cites it directly · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- Descendant · 2 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- Descendant · 3 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- Descendant · 4 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- Descendant · 4 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · cites it directly79descendants
- K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 2 generations on78descendants
- K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 3 generations on52descendants
- K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 4 generations on34descendants
- K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 4 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915192 | 7000 Series Modular Tibial Components | Osteonics Corp. | 1992 | — |
| −3 | K994128 | Scorpio Total Stablizer (TS) Total Knee System | Howmedica Osteonics Corp. | 2000 | 8 |
| −2 | K021313 | Search Evolution Total Knee System | Aesculap, Inc. | 2002 | — |
| −1 | K022672 | Columbus Total Knee System (CR) | Aesculap, Inc. | 2002 | 1 |
| 0 (this device) | K032108 | Search Evolution (LC) Total Knee System (Porous Coated) | Aesculap, Inc. | 2004 | — |
| +1 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| +2 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| +3 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| +4 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| +4 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 2 | 0 |
| 2025 | 9 | 0 |
| 2026 | 9 | 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? (4)
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 |
|---|---|---|---|
| * | K022672 | Columbus Total Knee System (CR)Summary page 2…hat the new porous coated femoral component of the Search Evolution Total Knee System is substantially equivalent in design to: * Columbus (CR) Total Knee System (K022672) * Search Evolution Total Knee System (K021313) * Scorpio Posterior Cruciate Retaining Knee System (K974556)… | 2002 |
| * | K021313 | Search Evolution Total Knee SystemSummary page 2…rch Evolution Total Knee System is substantially equivalent in design to: * Columbus (CR) Total Knee System (K022672) * Search Evolution Total Knee System (K021313) * Scorpio Posterior Cruciate Retaining Knee System (K974556) * Gem Knee System (K994214) Substantial equivalence… | 2002 |
| * | K974556 | Osteonics Scorpio Posterior Cruciate Retaining Total Knee SystemSummary page 2…n to: * Columbus (CR) Total Knee System (K022672) * Search Evolution Total Knee System (K021313) * Scorpio Posterior Cruciate Retaining Knee System (K974556) * Gem Knee System (K994214) Substantial equivalence to the intended use of uncemented fixation for the porous coated fe… | 1998 |
| * | K994214 | Gem Knee SystemSummary page 2…Knee System (K022672) * Search Evolution Total Knee System (K021313) * Scorpio Posterior Cruciate Retaining Knee System (K974556) * Gem Knee System (K994214) Substantial equivalence to the intended use of uncemented fixation for the porous coated femoral component is established by:… | 2000 |
What descends from it? (80)
See all 801 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | 2007 | 79 |
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- 6 of the 12 ancestors have a recall of any class.
- Of its descendants, K070981 (Aesculap Implant Systems, Inc., 2007) has gone furthest, with 79 descendants of its own.
- 6 other devices also cite its predicate K022672.
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 Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery,
The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.
The Search Evolution porous coated femoral component is designed for use without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032108 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032108: Search Evolution (LC) Total Knee System (Porous Coated).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032108
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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