510(k) Report

510(k) · Cleared

Recalled · 2008

Foundation Knee System

K923277510(k) TraditionalCleared Feb 9, 1993218-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 Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 9, 1993 after a 218-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 238 later devices descend from it. It has been recalled 4 times.

Decided
Feb 9, 1993
Review
218 days
Class
Class II
Product code
JWH
Recalls
4
Predicates
0

238 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2013: 13 descendants cleared2015: 9 descendants cleared2002: 3 descendants cleared1996: 2 descendants cleared1997: 1 descendant cleared2000: 1 descendant cleared2019: 10 descendants cleared2010: 5 descendants cleared2009: 2 descendants cleared2001: 1 descendant cleared2007: 1 descendant cleared2012: 11 descendants cleared2004: 1 descendant cleared2014: 15 descendants cleared2016: 13 descendants cleared2018: 7 descendants cleared2025: 20 descendants cleared2026: 16 descendants cleared2020: 17 descendants cleared2017: 10 descendants cleared2021: 28 descendants cleared2006: 2 descendants cleared2003: 1 descendant cleared2023: 22 descendants cleared2022: 18 descendants cleared2011: 2 descendants cleared2024: 7 descendants cleared1990200020102020
  1. This deviceK923277 Foundation Knee SystemEncore Orthopedics, Inc. · 1993
  2. Descendant · cites it directly · 143 of its ownK020114 3D KNEEEncore Orthopedics, Inc. · 2002 · Recalled
  3. Descendant · 2 generations on · 119 of its ownK091956 Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model…Encore Medical L.P. · 2010 · Recalled
  4. Descendant · cites it directly · 115 of its ownK000666 TC-Plus Solution KneePlus Orthopedics · 2000 · Recalled
  5. Descendant · cites it directly · 72 of its ownK100900 Motivation Knee SystemEncore Medical L.P. · 2010 · Recalled
  6. Descendant · 2 generations on · 70 of its ownK022204 VKS Knee SystemPlus Orthopedics · 2002 · Recalled

Showing 5 of 238 descendants. See all descendants

Descendants cleared per year

1996: 21997: 12000: 12001: 12002: 32003: 12004: 12006: 22007: 12009: 22010: 52011: 22012: 112013: 132014: 152015: 92016: 132017: 102018: 72019: 102020: 172021: 282022: 182023: 222024: 72025: 202026: 16
1996high 28 (2021) · low 0 (1998)2026

Most influential descendants

Showing 5 of 238 · See all
  • K0201143D KNEEEncore Orthopedics, Inc. · 2002 · cites it directly143descendants
  • K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P. · 2010 · 2 generations on119descendants
  • K000666TC-Plus Solution KneePlus Orthopedics · 2000 · cites it directly115descendants
  • K100900Motivation Knee SystemEncore Medical L.P. · 2010 · cites it directly72descendants
  • K022204VKS Knee SystemPlus Orthopedics · 2002 · 2 generations on70descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K923277Foundation Knee SystemEncore Orthopedics, Inc.1993—
+1K0201143D KNEEEncore Orthopedics, Inc.20025
+2K091956Highly Cross-Linked Vitamin E Uhmwpe Tibial Inserts, Model 391/392-09_19-702_712Encore Medical L.P.20104
+1K000666TC-Plus Solution KneePlus Orthopedics20009
+1K100900Motivation Knee SystemEncore Medical L.P.20104
+2K022204VKS Knee SystemPlus Orthopedics20024

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199710
200010
200110
200230
200310
200410
200620
200710
200920
201050
201120
2012110
2013130
2014150
201590
2016130
2017100
201870
2019100
2020170
2021280
2022180
2023220
202470
2025200
2026160
FIG. 1 — Lineage of K923277, 1993–2026Source: 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? (238)

See all 238

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

NumberDeviceApplicantDecidedDescendants
K0201143D KNEEEncore Orthopedics, Inc.2002143
K000666TC-Plus Solution KneePlus Orthopedics2000115
K100900Motivation Knee SystemEncore Medical L.P.201072
K090705Balanced Knee System Ultracongruent Tibial InsertOrtho Development Corp.200942
K964008Foundation Knee SystemEncore Orthopedics, Inc.199621
K122239Foundation Knee System with Tinbn Coating Foundation PS Knee System with Tinbn Coating…Encore Medical L.P.201320
K143242Rebel 3DKNEE SystemEncore Medical L.P.201511
K182872LINK GEMINI SL Total Knee SystemWaldemar Link GmbH & Co. KG20198
K120038A200 Knee SystemRenovis Surgical Technologies, LLC20132
K970031Foundation Knee System Tibial ComponentEncore Orthopedics, Inc.19970

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

Recalls of this device

DateClassRecallRoot causeReason
Aug 4, 2008Not classifiedZ-2466-2008Device DesignComplaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.
Nov 3, 2005Not classifiedZ-0331-06OtherThe product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.
May 10, 2004Not classifiedZ-1010-04OtherLabeling is switched for the two products recalled. 3DKNEE is labeled as Foundation and Foundation is labeled as 3DKNEE
Apr 24, 2003Not classifiedZ-1069-03OtherProduct container was labeled incorrectly indicating left femur instead of right.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K020114 (Encore Orthopedics, Inc., 2002) has gone furthest, with 143 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 Encore Orthopedics, Inc.

85 FDA decisions under this applicant name. See the company

  • K0329053DKNEE Porous Coated Femoral ComponentEncore Orthopedics, Inc. · 2004
  • K0201143D KNEEEncore Orthopedics, Inc. · 20025 recalls
  • K020741Unicondylar KneeEncore Orthopedics, Inc. · 20022 recalls
  • K020236Modification to Pass Spinal SystemEncore Orthopedics, Inc. · 2002
  • K020170Keystone Hip System Calcar Replacement Body and Build UPEncore Orthopedics, Inc. · 2002

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/K923277 · printed Nov 6, 2026

Cite this page

510(k) Report. “K923277: Foundation 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/K923277

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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