510(k) Report

510(k) · Cleared

Cleared

Search Evolution (LC) Total Knee System (Plasmapore)

K070981510(k) TraditionalCleared Aug 21, 2007137-day reviewClass II21 CFR 888.3560

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

Aesculap Implant Systems, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Aug 21, 2007 as substantially equivalent to K032108 (Aesculap, Inc., 2004) and 3 other predicates after a 137-day review. Its family tree reaches back 6 generations to 1994. 79 later devices descend from it.

Decided
Aug 21, 2007
Review
137 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
4

Its longest line of descent runs back 6 generations to K941847 (1994). 63 ancestors in all, the oldest K840643 (1984). 79 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 3 other ancestors2002: 5 other ancestors2003: 3 other ancestors2001: 4 other ancestors2000: 5 other ancestors1998: 5 other ancestors1996: 7 other ancestors1999: 2 other ancestors1997: 3 other ancestors1995: 4 other ancestors1994: 5 other ancestors1993: 2 other ancestors1992: 2 other ancestors1991: 1 other ancestor1990: 1 other ancestor1987: 2 other ancestors1984: 1 other ancestor1985: 1 other ancestor2008: 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 clearedK941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994K964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 14 other ancestors3 generations back: 18 other ancestors4 generations back: 13 other ancestors5 generations back: 8 other ancestors 1 generation forward: 1 descendant2 generations forward: 9 descendants3 generations forward: 21 descendants4 generations forward: 29 descendants5 generations forward: 13 descendants6 generations forward: 4 descendants7 generations forward: 2 descendants K042344 · Excia Total Hip System · Aesculap, Inc. · 2005 · recalledK031495 · Pinnacle Duofix HA Acetabular Cup Prosthesis · DePuy Orthopaedics, Inc. · 2003K001277 · Triflange Acetabular Cup System · DePuy Orthopaedics, Inc. · 2000K980711 · Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating · Zimmer, Inc. · 1998 · recalledK964650 · TCP-Coated Porocoat Aml Femoral Hip Prosthesis · Depuy, Inc. · 1997K941847 · 5/8 Porocoat Aml Hip Porocoat Porous Coating · Depuy, Inc. · 1994−50+5
  1. Root · 6 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
  2. 5 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
  3. 4 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
  4. 3 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
  5. 2 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
  6. 1 generation backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
  7. This deviceK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  8. Descendant · cites it directly · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
  9. Descendant · 2 generations on · 52 of its ownK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
  10. Descendant · 3 generations on · 34 of its ownK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
  11. Descendant · 3 generations on · 28 of its ownK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
  12. Descendant · 2 generations on · 23 of its ownK113571 GMK Resufacing Patella Size 4Medacta International · 2012

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2008: 12009: 22010: 22011: 52012: 82013: 62014: 32015: 12016: 12017: 32018: 32019: 12020: 52021: 92022: 42023: 52024: 22025: 92026: 9
2008high 9 (2021) · low 1 (2008)2026

Most influential descendants

Showing 5 of 79 · See all
  • K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · cites it directly78descendants
  • K090988GMK Total Knee SystemMedacta International S.A. · 2009 · 2 generations on52descendants
  • K102437GMK Revision Knee SystemMedacta International S.A. · 2010 · 3 generations on34descendants
  • K103170GMK Revision Knee SC LinersMedacta International S.A. · 2011 · 3 generations on28descendants
  • K113571GMK Resufacing Patella Size 4Medacta International · 2012 · 2 generations on23descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−6K9418475/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc.1994—
−5K964650TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc.1997—
−4K980711Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic CoatingZimmer, Inc.19981
−3K001277Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc.2000—
−2K031495Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc.2003—
−1K042344Excia Total Hip SystemAesculap, Inc.200510
0 (this device)K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
+1K081023Evolis Total Knee SystemMedacta International S.A.20081
+2K090988GMK Total Knee SystemMedacta International S.A.20091
+3K102437GMK Revision Knee SystemMedacta International S.A.2010—
+3K103170GMK Revision Knee SC LinersMedacta International S.A.2011—
+2K113571GMK Resufacing Patella Size 4Medacta International2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
198720
199010
199110
199220
199320
199450
199540
199670
199730
199850
199920
200050
200140
200250
200330
200430

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200920
201020
201150
201280
201360
201430
201510
201610
201730
201830
201910
202050
202190
202240
202350
202420
202590
202690
FIG. 1 — Lineage of K070981, 1994–2026Source: 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 JWH? 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 JWH device

  1. #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K032108Search Evolution (LC) Total Knee System (Porous Coated)
Summary page 1
…System is substantially equivalent in design fundamental technology, and coating when compared to: * Aesculap Search Evolution Porous Coated Femoral Component (K032108) * Aesculap Bicontact Hip System (K040191) * Aesculap Excia Total Hip System (K042344) * Aesculap Search…
Aesculap, Inc.2004—
*K040191Bicontact Hip Stem and Femoral Head
Summary page 1
…amental technology, and coating when compared to: * Aesculap Search Evolution Porous Coated Femoral Component (K032108) * Aesculap Bicontact Hip System (K040191) * Aesculap Excia Total Hip System (K042344) * Aesculap Search Evolution Total Knee System (K021313) DEVICE DES…
Aesculap2004—
*K042344Excia Total Hip System
Summary page 1
…* Aesculap Search Evolution Porous Coated Femoral Component (K032108) * Aesculap Bicontact Hip System (K040191) * Aesculap Excia Total Hip System (K042344) * Aesculap Search Evolution Total Knee System (K021313) DEVICE DESCRIPTION The Search Evolution (LC) Total Knee Syste…
Aesculap, Inc.200510
*K021313Search Evolution Total Knee System
Summary page 1
…nt (K032108) * Aesculap Bicontact Hip System (K040191) * Aesculap Excia Total Hip System (K042344) * Aesculap Search Evolution Total Knee System (K021313) DEVICE DESCRIPTION The Search Evolution (LC) Total Knee System is available with two fernoral designs. Each retains the PCL,…
Aesculap, Inc.2002—

What descends from it? (79)

See all 79

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

NumberDeviceApplicantDecidedDescendants
K081023Evolis Total Knee SystemMedacta International S.A.200878

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 13 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
  • 21 of the 62 ancestors have a recall of any class.
  • Of its descendants, K081023 (Medacta International S.A., 2008) has gone furthest, with 78 descendants of its own.

How does its category compare?

All JWH devices

JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JWH

20in 2025

2007: 182008: 172009: 112010: 192011: 252012: 332013: 312014: 332015: 272016: 182017: 252018: 252019: 282020: 222021: 242022: 172023: 202024: 192025: 202026 (partial year): 12
2007high 33 (2012) · low 11 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JWH

55in 2025

2007: 74 days median2008: 81 days median2009: 168 days median2010: 85 days median2011: 87 days median2012: 85 days median2013: 128 days median2014: 98 days median2015: 87 days median2016: 88 days median2017: 118 days median2018: 90 days median2019: 133 days median2020: 59 days median2021: 61 days median2022: 56 days median2023: 57 days median2024: 89 days median2025: 55 days median2026 (partial year): 63 days median
2007high 168 (2009) · low 55 (2025)2026

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

Recalls per year · JWH

2in 2025

2007: 142008: 102009: 1092010: 322011: 272012: 852013: 312014: 132015: 112016: 172017: 612018: 142019: 52020: 22021: 82022: 122023: 672024: 72025: 22026 (partial year): 4
2007high 109 (2009) · low 2 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JWH

9,306in 2025

2007: 1,3052008: 1,4832009: 1,8702010: 3,2862011: 5,1332012: 5,2032013: 6,1352014: 6,7222015: 6,8812016: 7,5862017: 12,2632018: 14,0712019: 14,9872020: 12,5922021: 9,4082022: 8,3642023: 8,9472024: 10,8282025: 9,306
2007high 14,987 (2019) · low 1,305 (2007)2025

MAUDE reports naming product code JWH, 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
20071874141,305
20081781101,483
2009111681091,870
20101985323,286
20112587275,133
20123385855,203
201331128316,135
20143398136,722
20152787116,881
20161888177,586
2017251186112,263
201825901414,071
201928133514,987
20202259212,592
2021246189,408
20221756128,364
20232057678,947
20241989710,828
2025205529,306
202612634—

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 non-porous titanium plasma spray coated femoral components are designed for use with bone cement.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K070981: Search Evolution (LC) Total Knee System (Plasmapore).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070981

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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