510(k) Report

510(k) · Cleared

Recalled · 2010

Foundation Metal-Backed Patella

K932246510(k) TraditionalCleared Jul 22, 1994438-day reviewClass II21 CFR 888.3560Recalls 1

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 Jul 22, 1994 after a 438-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 37 later devices descend from it. It has been recalled once.

Decided
Jul 22, 1994
Review
438 days
Class
Class II
Product code
JWH
Recalls
1
Predicates
0

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

Descendants, by year cleared 1997: 1 descendant cleared2012: 2 descendants cleared2013: 4 descendants cleared2016: 5 descendants cleared2014: 6 descendants cleared2018: 1 descendant cleared2020: 3 descendants cleared2021: 5 descendants cleared2019: 1 descendant cleared2015: 1 descendant cleared2023: 5 descendants cleared2022: 2 descendants cleared2025: 1 descendant cleared1990200020102020
  1. This deviceK932246 Foundation Metal-Backed PatellaEncore Orthopedics, Inc. · 1994
  2. 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
  3. Descendant · 2 generations on · 33 of its ownK122870 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  4. Descendant · 3 generations on · 30 of its ownK131467 Itotal Cruciate Retaining (CR) Knee Replacement SystemConformis, Inc. · 2013
  5. Descendant · 3 generations on · 30 of its ownK131019 Itotal Cruciate Retaining (C) Knee Replacement SystemConformis, Inc. · 2013
  6. Descendant · 4 generations on · 26 of its ownK140833 Itotal Posterior Stabilized (PS) Knee Replacement SystemConformis, Inc. · 2014

Showing 5 of 37 descendants. See all descendants

Descendants cleared per year

1997: 12012: 22013: 42014: 62015: 12016: 52018: 12019: 12020: 32021: 52022: 22023: 52025: 1
1997high 6 (2014) · low 0 (1998)2026

Most influential descendants

Showing 5 of 37 · 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
0 (this device)K932246Foundation Metal-Backed PatellaEncore Orthopedics, Inc.1994—
+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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
201220
201340
201460
201510
201650
201810
201910
202030
202150
202220
202350
202510
FIG. 1 — Lineage of K932246, 1994–2025Source: 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
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (37)

See all 37

2 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
K973672Foundation Plasma Sprayed Metal-Backed PatellaEncore Orthopedics, Inc.19970

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

Recalls of this device

DateClassRecallRoot causeReason
Feb 22, 2010Not classifiedZ-1255-2010Process controlOne lot of product was incorrectly manufactured. Pegs are larger than specification.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K113756 (Encore Medical L.P., 2012) has gone furthest, with 35 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

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  • 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/K932246 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932246: Foundation Metal-Backed Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932246

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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