510(k) Report

510(k) · Cleared

Cleared

Search Evolution (LC) Total Knee System (Porous Coated)

K032108510(k) AbbreviatedCleared Jan 15, 2004191-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

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.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1998: 2 other ancestors2001: 1 other ancestor1996: 2 other ancestors1993: 1 other ancestor1992: 1 other ancestor2007: 1 descendant cleared2008: 1 descendant cleared2011: 5 descendants cleared2009: 2 descendants cleared2014: 3 descendants cleared2012: 8 descendants cleared2013: 6 descendants cleared2010: 2 descendants cleared2022: 4 descendants cleared2020: 5 descendants cleared2024: 2 descendants cleared2026: 9 descendants cleared2023: 5 descendants cleared2017: 3 descendants cleared2021: 9 descendants cleared2018: 3 descendants cleared2016: 1 descendant cleared2025: 9 descendants cleared2019: 1 descendant cleared2015: 1 descendant clearedK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 1992K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalled×2: 2 generations cleared close together, K021313 (2002), K022672 (2002) 1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 9 descendants4 generations forward: 21 descendants5 generations forward: 29 descendants6 generations forward: 13 descendants7 generations forward: 4 descendants8 generations forward: 2 descendants K022672 · Columbus Total Knee System (CR) · Aesculap, Inc. · 2002 · recalledK021313 · Search Evolution Total Knee System · Aesculap, Inc. · 2002K994128 · Scorpio Total Stablizer (TS) Total Knee System · Howmedica Osteonics Corp. · 2000 · recalledK915192 · 7000 Series Modular Tibial Components · Osteonics Corp. · 19920+5
  1. Root · 4 generations backK915192 7000 Series Modular Tibial ComponentsOsteonics Corp. · 1992
  2. 3 generations backK994128 Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp. · 2000 · Recalled
  3. 2 generations backK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
  4. 1 generation backK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
  5. This deviceK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
  6. Descendant · cites it directly · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  7. Descendant · 2 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
  8. Descendant · 3 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
  9. Descendant · 4 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
  10. 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

2007: 12008: 12009: 22010: 22011: 52012: 82013: 62014: 32015: 12016: 12017: 32018: 32019: 12020: 52021: 92022: 42023: 52024: 22025: 92026: 9
2007high 9 (2021) · low 1 (2007)2026

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

GenerationNumberDeviceApplicantDecidedRecalls
−4K9151927000 Series Modular Tibial ComponentsOsteonics Corp.1992—
−3K994128Scorpio Total Stablizer (TS) Total Knee SystemHowmedica Osteonics Corp.20008
−2K021313Search Evolution Total Knee SystemAesculap, Inc.2002—
−1K022672Columbus Total Knee System (CR)Aesculap, Inc.20021
0 (this device)K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.2004—
+1K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
+2K081023Evolis Total Knee SystemMedacta International S.A.20081
+3K090988GMK Total Knee SystemMedacta International S.A.20091
+4K102437GMK Revision Knee SystemMedacta International S.A.2010—
+4K103170GMK Revision Knee SC LinersMedacta International S.A.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199310
199620
199820
200010
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
200920
201020
201150
201280
201360
201430
201510
201610
201730
201830
201910
202050
202190
202240
202350
202420
202590
202690
FIG. 1 — Lineage of K032108, 1992–2026Source: 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 19.9 · 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K022672Columbus 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)…
Aesculap, Inc.20021
*K021313Search Evolution Total Knee System
Summary 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…
Aesculap, Inc.2002—
*K974556Osteonics Scorpio Posterior Cruciate Retaining Total Knee System
Summary 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…
Osteonics Corp.19987
*K994214Gem Knee System
Summary 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:…
Kinamed, Inc.2000—

Also cleared against K022672: 6 other devices →

What descends from it? (80)

See all 80

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.200779

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 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 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.

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