510(k) Report

510(k) · Cleared

Recalled · Class II · 2017

Motivation Knee System

K100900510(k) TraditionalCleared Jun 18, 201079-day reviewClass II21 CFR 888.3560Recalls 4

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

Encore Medical L.P. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jun 18, 2010 as substantially equivalent to K905613 (T & R Mfg., Inc., 1991) and 10 other predicates after a 79-day review. Its family tree reaches back 3 generations to 1994. 72 later devices descend from it. It has been recalled 4 times.

Decided
Jun 18, 2010
Review
79 days
Class
Class II
Product code
JWH
Recalls
4
Predicates
11

Its longest line of descent runs back 3 generations to K936079 (1994). 17 ancestors in all, the oldest K810520 (1981). 72 later devices descend from it, 8 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1995: 3 other ancestors1994: 4 other ancestors1993: 1 other ancestor1991: 1 other ancestor2000: 1 other ancestor1996: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor2016: 8 descendants cleared2014: 7 descendants cleared2012: 3 descendants cleared2018: 3 descendants cleared2013: 5 descendants cleared2015: 2 descendants cleared2019: 4 descendants cleared2025: 5 descendants cleared2026: 1 descendant cleared2020: 5 descendants cleared2022: 5 descendants cleared2017: 2 descendants cleared2021: 14 descendants cleared2023: 8 descendants clearedK936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 1994K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K030686 · Optetrak Total Knee System - Molded Metal-Back Tibial Component · Exactech, Inc. · 200319801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 9 other ancestors2 generations back: 5 other ancestors 1 generation forward: 8 descendants2 generations forward: 12 descendants3 generations forward: 17 descendants4 generations forward: 11 descendants5 generations forward: 5 descendants6 generations forward: 8 descendants7 generations forward: 3 descendants8 generations forward: 3 descendants9 generations forward: 3 descendants10 generations forward: 2 descendants K030686 · Optetrak Total Knee System - Molded Metal-Back Tibial Component · Exactech, Inc. · 2003K011976 · Optetrak Total Knee System Size 0/1 Delta (Line Extension) · Exactech, Inc. · 2001K936079 · Ecactech Porous Coated Finned Tibial Tray Compnent · Exactech, Inc. · 19940+5+10
  1. Root · 3 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 2 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 1 generation backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  4. This deviceK100900 Motivation Knee SystemEncore Medical L.P. · 2010
  5. Descendant · cites it directly · 35 of its ownK113756 Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 2012 · Recalled
  6. Descendant · 2 generations on · 33 of its ownK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  7. Descendant · 3 generations on · 30 of its ownK131467 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  8. Descendant · 3 generations on · 30 of its ownK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
  9. Descendant · 4 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014

Showing 5 of 72 descendants. See all descendants

Descendants cleared per year

2012: 32013: 52014: 72015: 22016: 82017: 22018: 32019: 42020: 52021: 142022: 52023: 82025: 52026: 1
2012high 14 (2021) · low 0 (2024)2026

Most influential descendants

Showing 5 of 72 · See all
  • K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P. · 2012 · cites it directly35descendants
  • K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 2 generations on33descendants
  • K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013 · 3 generations on30descendants
  • K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013 · 3 generations on30descendants
  • K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014 · 4 generations on26descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−2K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−1K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.2003—
0 (this device)K100900Motivation Knee SystemEncore Medical L.P.2010—
+1K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg…Encore Medical L.P.20121
+2K122870Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2013—
+3K131467Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc.2013—
+3K131019Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc.2013—
+4K140833Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
199110
199310
199440
199530
199610
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201230
201350
201470
201520
201680
201720
201830
201940
202050
2021140
202250
202380
202550
202610
FIG. 1 — Lineage of K100900, 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
Get a 510(k) Report

What was it cleared against? (11)

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
*K905613MTS Knee System
Summary page 1
…Encore Medical Encore Medical Exactech 510(k) Reference K905613, K923277, K0201 14 K932690, K932776,…
T & R Mfg., Inc.1991—
*K923277Foundation Knee System
Summary page 1
…Encore Medical Encore Medical Exactech 510(k) Reference K905613, K923277, K0201 14 K932690, K932776,…
Encore Orthopedics, Inc.19934
*K932425Foundation Modular Tibial Baseplate
Summary page 1
…K905613, K923277, K0201 14 K932690, K932776, K932425, K933539 K933494, K93361 0,…
Encore Orthopedics, Inc.19942
*K933539Foundation Posterior Stabilized Knee
Summary page 1
…K905613, K923277, K0201 14 K932690, K932776, K932425, K933539 K933494, K93361 0, __…
Encore Orthopedics, Inc.1994—
*K0201143D KNEE
Summary page 1
…Encore Medical Exactech 510(k) Reference K905613, K923277, K0201 14 K932690, K932776, K932425, K933539…
Encore Orthopedics, Inc.20025
*K932690Exactech Cruciate Retaining Cemented Total Knee SY
Summary page 1
…Exactech 510(k) Reference K905613, K923277, K0201 14 K932690, K932776, K932425, K933539…
Exactech, Inc.19956
*K932776Cruciate Retaining Cemented Tibial Components
Summary page 1
…Exactech 510(k) Reference K905613, K923277, K0201 14 K932690, K932776, K932425, K933539…
Exactech, Inc.19942
*K933494Exactech Posterior Stabilized Cemented Total Knee System
Summary page 1
…K932690, K932776, K932425, K933539 K933494, K93361 0, ____ ___ ____…
Exactech, Inc.19952
*K933610Exactech Cemented Total Knee System, Tibial Components
Summary page 1
…K932690, K932776, K932425, K933539 K933494, K93361 0, ____ ___ ____ ____…
Exactech, Inc.19957
*K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
*K030686Optetrak Total Knee System - Molded Metal-Back Tibial Component
Summary page 1
…___ ____ ____ ___ ___ ____ ___ ___ ____ ____ ___ KOI 1976, K030686 Comparable Features to Predicate Device: The Movation and Optetrak femurs exhibit an asymmetric anterior flange.…
Exactech, Inc.2003—

Also cleared against K905613: 2 other devices →

What descends from it? (72)

See all 72

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

NumberDeviceApplicantDecidedDescendants
K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly…Encore Medical L.P.201235
K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320
K121727Movation Knee SystemEncore Medical L.P.201214
K143242Rebel 3DKNEE SystemEncore Medical L.P.201511
K140830Exprt Revision KneeEncore Medical L.P.20147
K160342EMPOWR PS Knee SystemEncore Medical L.P.20166
K173723EMPOWR Universal Tibial BaseplateEncore Medical L.P.20182
K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P.20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Dec 12, 2017Class IIZ-0327-2018Device DesignThe Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Dec 12, 2017Class IIZ-0328-2018Device DesignThe Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Dec 12, 2017Class IIZ-0326-2018Device DesignThe Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
Dec 12, 2017Class IIZ-0329-2018Device DesignThe Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 16 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
  • 9 of the 17 ancestors have a recall of any class.
  • Of its descendants, K113756 (Encore Medical L.P., 2012) has gone furthest, with 35 descendants of its own.
  • 2 other devices also cite its predicate K905613.

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. 2010, 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?

Joint replacement is indicated for patients suffering from disability due to:

*degenerative, post-traumatic or rheumatoid arthritis;

*avascular necrosis of the femoral condyle;

*post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

*moderate valgus, varus or flexion deformities;

*treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts.

This system is intended to be used for cemented applications.

Indications for use as stated in the FDA summary.

Also cleared against K905613

2 other devices cite the same predicate.

  • K121835Domed Tri-Peg Patella, Highly Cross Linked Domed Tri-Peg Patella with VEEncore Medical L.P. · 2012
  • K113756Highly Cross Linked VE Central Peg Patella Highly Cross Linked VE Tri-Peg Patella Highly Cross Linked VE…Encore Medical L.P. · 20121 recall

More from Encore Medical L.P.

82 FDA decisions under this applicant name. See the company

  • K263086AltiVate Reverse® Glenosphere with RAVN™ TechnologyEncore Medical L.P. · 2026
  • K252567AltiVate Reverse® ADLC GlenosphereEncore Medical L.P. · 2026
  • K252974EMPOWR KneeEncore Medical L.P. · 2025
  • K251833EMPOWR Acetabular® Liner ExtensionEncore Medical L.P. · 2025
  • K252141AltiVate Reverse® GlenoidEncore Medical L.P. · 2025

Recent decisions in JWH

The JWH category page

  • K262057GMK ExtensionMedacta International SA · 2026
  • K260063GSPE SpacerThe General Hospital Corporation, d/b/a Massachusetts · 2026
  • K262293EVOLUTION MPX™ Total Knee SystemSuzhou Microport Orthorecon Co., Ltd. · 2026
  • K262341b-ONE® Mobio™ Total Knee System Revision Cemented Tibial Augments, Stem Extensions and Press-Fit Stem…B-One Ortho, Corp. · 2026
  • K262130ATTUNE Revision Knee SystemDepuy Orthopaedics, Inc. · 2026

https://510kreport.com/device/K100900 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100900: Motivation 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/K100900

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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