510(k) Report

510(k) · Cleared

Cleared

Gem Posterior Stabilized Total Knee System

K010101510(k) TraditionalCleared May 17, 2001126-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

Kinamed, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on May 17, 2001 after a 126-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 121 later devices descend from it.

Decided
May 17, 2001
Review
126 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 3 descendants cleared2003: 1 descendant cleared2004: 2 descendants cleared2007: 3 descendants cleared2009: 3 descendants cleared2014: 4 descendants cleared2006: 2 descendants cleared2015: 5 descendants cleared2008: 2 descendants cleared2012: 10 descendants cleared2010: 3 descendants cleared2019: 3 descendants cleared2011: 5 descendants cleared2013: 8 descendants cleared2021: 13 descendants cleared2025: 13 descendants cleared2022: 6 descendants cleared2020: 7 descendants cleared2024: 4 descendants cleared2026: 10 descendants cleared2023: 7 descendants cleared2017: 3 descendants cleared2018: 3 descendants cleared2016: 1 descendant cleared200020052010201520202025
  1. This deviceK010101 Gem Posterior Stabilized Total Knee SystemKinamed, Inc. · 2001
  2. Descendant · cites it directly · 120 of its ownK021313 Search Evolution Total Knee SystemAesculap, Inc. · 2002
  3. Descendant · 2 generations on · 96 of its ownK022672 Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · Recalled
  4. Descendant · 2 generations on · 80 of its ownK032108 Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004
  5. Descendant · 2 generations on · 79 of its ownK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
  6. Descendant · 3 generations on · 78 of its ownK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled

Showing 5 of 121 descendants. See all descendants

Descendants cleared per year

2002: 32003: 12004: 22006: 22007: 32008: 22009: 32010: 32011: 52012: 102013: 82014: 42015: 52016: 12017: 32018: 32019: 32020: 72021: 132022: 62023: 72024: 42025: 132026: 10
2002high 13 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 121 · See all
  • K021313Search Evolution Total Knee SystemAesculap, Inc. · 2002 · cites it directly120descendants
  • K022672Columbus Total Knee System (CR)Aesculap, Inc. · 2002 · 2 generations on96descendants
  • K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc. · 2004 · 2 generations on80descendants
  • K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007 · 2 generations on79descendants
  • K081023Evolis Total Knee SystemMedacta International S.A. · 2008 · 3 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010101Gem Posterior Stabilized Total Knee SystemKinamed, Inc.2001—
+1K021313Search Evolution Total Knee SystemAesculap, Inc.2002—
+2K022672Columbus Total Knee System (CR)Aesculap, Inc.20021
+2K032108Search Evolution (LC) Total Knee System (Porous Coated)Aesculap, Inc.2004—
+2K070981Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc.2007—
+3K081023Evolis Total Knee SystemMedacta International S.A.20081

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200230
200310
200420
200620
200730
200820
200930
201030
201150
2012100
201380
201440
201550
201610
201730
201830
201930
202070
2021130
202260
202370
202440
2025130
2026100
FIG. 1 — Lineage of K010101, 2001–2026Source: 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), 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
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (121)

See all 121

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

NumberDeviceApplicantDecidedDescendants
K021313Search Evolution Total Knee SystemAesculap, Inc.2002120
K030367Columbus (PS)Aesculap, Inc.200317

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, K021313 (Aesculap, Inc., 2002) has gone furthest, with 120 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.

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—

More from Kinamed, Inc.

33 FDA decisions under this applicant name. See the company

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  • K033668Navipro Knee Software ModuleKinamed, Inc. · 2004
  • K032950Gem Inset Patellar ComponentKinamed, Inc. · 2003

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https://510kreport.com/device/K010101 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010101: Gem Posterior Stabilized Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010101

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026