510(k) Report

510(k) · Cleared

Cleared

Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating

K122239510(k) TraditionalCleared Apr 11, 2013258-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

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

Cleared on Apr 11, 2013 as substantially equivalent to K923277 (Encore Orthopedics, Inc., 1993) and 4 other predicates after a 258-day review. Its family tree reaches back 4 generations to 1994. 20 later devices descend from it.

Decided
Apr 11, 2013
Review
258 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K936079 (1994). 19 ancestors in all, the oldest K810520 (1981). 20 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1996: 2 other ancestors1994: 4 other ancestors1993: 1 other ancestor2000: 1 other ancestor1995: 3 other ancestors1991: 1 other ancestor1984: 1 other ancestor1981: 1 other ancestor2016: 1 descendant cleared2019: 3 descendants cleared2025: 2 descendants cleared2026: 1 descendant cleared2020: 2 descendants cleared2021: 8 descendants cleared2022: 2 descendants cleared2023: 1 descendant 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. · 2003K100900 · Motivation Knee System · Encore Medical L.P. · 2010 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 4 other ancestors 1 generation forward: 6 descendants2 generations forward: 9 descendants3 generations forward: 5 descendants K100900 · Motivation Knee System · Encore Medical L.P. · 2010 · recalledK030686 · 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
  1. Root · 4 generations backK936079 Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc. · 1994
  2. 3 generations backK011976 Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc. · 2001
  3. 2 generations backK030686 Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc. · 2003
  4. 1 generation backK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
  5. This deviceK122239 Foundation Knee System with Tinbn Coating Foundation PS Knee System…Encore Medical L.P. · 2013
  6. Descendant · cites it directly · 9 of its ownK152431 LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled…Waldemar Link GmbH & Co. KG · 2016 · Recalled
  7. Descendant · cites it directly · 8 of its ownK182872 LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
  8. Descendant · 2 generations on · 3 of its ownK202684 GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020
  9. Descendant · 2 generations on · 2 of its ownK202924 LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · Recalled
  10. Descendant · cites it directly · 2 of its ownK200912 Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020

Showing 5 of 20 descendants. See all descendants

Descendants cleared per year

2016: 12019: 32020: 22021: 82022: 22023: 12025: 22026: 1
2016high 8 (2021) · low 0 (2017)2026

Most influential descendants

Showing 5 of 20 · See all
  • K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG · 2016 · cites it directly9descendants
  • K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019 · cites it directly8descendants
  • K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A. · 2020 · 2 generations on3descendants
  • K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG · 2021 · 2 generations on2descendants
  • K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc. · 2020 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K936079Ecactech Porous Coated Finned Tibial Tray CompnentExactech, Inc.1994—
−3K011976Optetrak Total Knee System Size 0/1 Delta (Line Extension)Exactech, Inc.2001—
−2K030686Optetrak Total Knee System - Molded Metal-Back Tibial ComponentExactech, Inc.2003—
−1K100900Motivation Knee SystemEncore Medical L.P.20104
0 (this device)K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn…Encore Medical L.P.2013—
+1K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System…Waldemar Link GmbH & Co. KG201616
+1K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG2019—
+2K202684GMK Total Knee System - TiNbN CoatingMedacta International S.A.2020—
+2K202924LinkSymphoKnee SystemWaldemar Link GmbH & Co. KG202111
+1K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198110
198410
199110
199310
199440
199530
199620
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
201930
202020
202180
202220
202310
202520
202610
FIG. 1 — Lineage of K122239, 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? (5)

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
*K923277Foundation Knee System
Summary page 1
…al.com Product Original 510(k) Number, Clearance Date/ Classification Prodc Code Fo-undation® Knee System K923277, Febmrun 9, 1993 / Class 11 JWHV Foundation® PS Knee System K933539, November 8, 1994…
Encore Orthopedics, Inc.19934
*K933539Foundation Posterior Stabilized Knee
Summary page 1
…dc Code Fo-undation® Knee System K923277, Febmrun 9, 1993 / Class 11 JWHV Foundation® PS Knee System K933539, November 8, 1994 / Class 1I JWH 3DKnee TM System K0201 14, July 12, 2002…
Encore Orthopedics, Inc.1994—
*K0201143D KNEE
Summary page 1
…JWHV Foundation® PS Knee System K933539, November 8, 1994 / Class 1I JWH 3DKnee TM System K0201 14, July 12, 2002 / Class 11JW Product Code I-Regulation and Classification Name JWH…
Encore Orthopedics, Inc.20025
*K100900Motivation Knee System
Summary page 1
…ation® Knee System, K923277 * JO Surgical, Foundation® PS Knee System, K933593 * DJO Surgical, 3DKneeTM System, K0201 14 *DJO Surgical, Movation Knee System, K 100900 *DJO Surgical, Foundation® Plasma Coated Femur, K964008 Comparable Features to Predicate Device(s): Features comparable to…
Encore Medical L.P.20104
*K964008Foundation Knee System
Summary page 1
…Knee System, K933593 * DJO Surgical, 3DKneeTM System, K0201 14 *DJO Surgical, Movation Knee System, K 100900 *DJO Surgical, Foundation® Plasma Coated Femur, K964008 Comparable Features to Predicate Device(s): Features comparable to predicate devices include the same indications, dimension…
Encore Orthopedics, Inc.1996—

Also cleared against K923277: 10 other devices →

What descends from it? (20)

See all 20

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

NumberDeviceApplicantDecidedDescendants
K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx…Waldemar Link GmbH & Co. KG20169
K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198
K200912Freedom (R) - TiNbN Coated KneeMaxx Orthopedics, Inc.20202
K191765OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc.20192
K241180Consensus Knee System with TiNbNShalby Advanced Technologies20251
K260796Tahoe Unicondylar Knee System with TiNbN OvercoatShalby Advanced Technologies, Inc. Dba Consensus Orthopedics20260

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 19 years and passes through 2 companies; a new generation was cleared every 6.9 years on median.
  • 10 of the 19 ancestors have a recall of any class.
  • Of its descendants, K152431 (Waldemar Link GmbH & Co. KG, 2016) has gone furthest, with 9 descendants of its own.
  • 10 other devices also cite its predicate K923277.

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. 2013, 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.

The device is intended for cemented applications.

Indications for use as stated in the FDA summary.

Also cleared against K923277

10 other devices cite the same predicate.

  • K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG · 2019
  • K143242Rebel 3DKNEE SystemEncore Medical L.P. · 201517 recalls
  • K120038A200 Knee SystemRenovis Surgical Technologies, LLC · 2013
  • K100900Motivation Knee SystemEncore Medical L.P. · 20104 recalls
  • K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp. · 20091 recall
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls

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/K122239 · printed Nov 6, 2026

Cite this page

510(k) Report. “K122239: Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating 3DKNEE System with Tinbn Coating.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K122239

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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