510(k) Report

510(k) · Cleared

Cleared

Foundation Plasma Sprayed Metal-Backed Patella

K973672510(k) TraditionalCleared Dec 18, 199783-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 Orthopedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Dec 18, 1997 as substantially equivalent to K932246 (Encore Orthopedics, Inc., 1994) and 2 other predicates after an 83-day review. Its family tree reaches back 1 generation to 1986.

Decided
Dec 18, 1997
Review
83 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K863805 (1986). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1994: 1 other ancestor1988: 1 other ancestorK863805 · Miller/Galante Total Knee Por Coated Patellar Dome · Zimmer, Inc. · 19861986198819901992199419961998
Other ancestors, by generation 1 generation back: 2 other ancestors K863805 · Miller/Galante Total Knee Por Coated Patellar Dome · Zimmer, Inc. · 19860
  1. Root · 1 generation backK863805 Miller/Galante Total Knee Por Coated Patellar DomeZimmer, Inc. · 1986
  2. This deviceK973672 Foundation Plasma Sprayed Metal-Backed PatellaEncore Orthopedics, Inc. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K863805Miller/Galante Total Knee Por Coated Patellar DomeZimmer, Inc.1986—
0 (this device)K973672Foundation Plasma Sprayed Metal-Backed PatellaEncore Orthopedics, Inc.1997—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810
199410
FIG. 1 — Lineage of K973672, 1986–1997Source: 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
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What was it cleared against? (3)

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
*K932246Foundation Metal-Backed Patella
Summary page 1
…tal-backed Patella is the very same device in regards to articulating geometry, assembly, and indications for usage as the Porous Coated Metal-backed patella approved in K932246. The only difference is the coating applied. The Foundation® Plasma Sprayed Metal-backed Patella is equivalent in design and indi…
Encore Orthopedics, Inc.19941
*K863805Miller/Galante Total Knee Por Coated Patellar Dome
Summary page 1
…o the Miller/Galante (Zimmer) and Natural-Knee (Sulzer Orthopedics) metal-backed patella (Exhibit VII). These devices were cleared for commercial distribution on 510(k)s K863805 and K873601, respectively. Similarities include, metal-backed baseplate with Ti-6A1-4V substrate, “sombrero” shaped articulating…
Zimmer, Inc.1986—
*K873601Agc Unicompartmental Knee Prosthesis
Summary page 1
…/Galante (Zimmer) and Natural-Knee (Sulzer Orthopedics) metal-backed patella (Exhibit VII). These devices were cleared for commercial distribution on 510(k)s K863805 and K873601, respectively. Similarities include, metal-backed baseplate with Ti-6A1-4V substrate, “sombrero” shaped articulating surface and…
Biomet, Inc.1988—

Also cleared against K932246: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • 1 of the 3 ancestors has a recall of any class.
  • 1 other device also cites its predicate K932246.

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—

What is it indicated for?

The Foundation® Plasma Sprayed Metal-backed Patella is intended to be used us a cemented patellar surface replacement in treating patients who are candidates for primary total knee arthroplsty as a result of osteoarthritis, inflammatory arthritis, traumatic arthritis or rheumatoid arthritis with or without varus, valgus, or flexion deformities. or revision arthroplasty where bone loss is minimal. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K932246

1 other device cites the same predicate.

  • 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 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/K973672 · printed Nov 4, 2026

Cite this page

510(k) Report. “K973672: Foundation Plasma Sprayed Metal-Backed Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973672

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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