510(k) Report

510(k) · Cleared

Cleared

Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision System

K982585510(k) TraditionalCleared Oct 5, 199873-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

DePuy Orthopaedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Oct 5, 1998 as substantially equivalent to K864671 (Depuy, Inc., 1987) and 5 other predicates after a 73-day review. Its family tree reaches back 1 generation to 1987.

Decided
Oct 5, 1998
Review
73 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K864671 (1987). 6 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 2 other ancestors1995: 1 other ancestor1991: 1 other ancestorK864671 · Anatomic Modular Knee (Amk) System · Depuy, Inc. · 19871985199019952000
Other ancestors, by generation 1 generation back: 5 other ancestors K864671 · Anatomic Modular Knee (Amk) System · Depuy, Inc. · 19870
  1. Root · 1 generation backK864671 Anatomic Modular Knee (Amk) SystemDepuy, Inc. · 1987
  2. This deviceK982585 Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision…DePuy Orthopaedics, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K864671Anatomic Modular Knee (Amk) SystemDepuy, Inc.1987—
0 (this device)K982585Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision SystemDePuy Orthopaedics, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199110
199510
199620
199710
FIG. 1 — Lineage of K982585, 1987–1998Source: 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? (6)

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
*K864671Anatomic Modular Knee (Amk) System
Summary page 1
…rotibial, Semiconstrained, Cemented, Polymer, Metal, Polymer DEVICE PRODUCT CODE: 87 JWH SUBSTANTIALLY EQUIVALENT DEVICES: (DePuy) Anatomic Modular Knee (AMK) System (K864671) (DePuy)Anatomic Modular Knee (AMK) Polyethylene Tibial Tray (K910940) (DePuy) AMK Polyethylene Posterior Stabilized Tibial Tray…
Depuy, Inc.1987—
*K910940Anatomic Modular Knee Polyethylene Tibial Tray
Summary page 1
…RODUCT CODE: 87 JWH SUBSTANTIALLY EQUIVALENT DEVICES: (DePuy) Anatomic Modular Knee (AMK) System (K864671) (DePuy)Anatomic Modular Knee (AMK) Polyethylene Tibial Tray (K910940) (DePuy) AMK Polyethylene Posterior Stabilized Tibial Tray (K943299) (DePuy) AMK Congruency Posterior Stabilized Insert (K954684)…
Depuy, Inc.1991—
*K943299Depuy Amk All Polyethylene Posterior Stablilized Tibial Tray
Summary page 1
…omic Modular Knee (AMK) System (K864671) (DePuy)Anatomic Modular Knee (AMK) Polyethylene Tibial Tray (K910940) (DePuy) AMK Polyethylene Posterior Stabilized Tibial Tray (K943299) (DePuy) AMK Congruency Posterior Stabilized Insert (K954684) (DePuy) Coordinate II (Ultra) Knee Revision System (K955884) (DeP…
Depuy, Inc.1995—
*K954684Depuy Anatomic Modular Knee (Amk) Congruency Posterior Stabilized Tibial Insert
Summary page 1
…lar Knee (AMK) Polyethylene Tibial Tray (K910940) (DePuy) AMK Polyethylene Posterior Stabilized Tibial Tray (K943299) (DePuy) AMK Congruency Posterior Stabilized Insert (K954684) (DePuy) Coordinate II (Ultra) Knee Revision System (K955884) (DePuy) Duraloc Acetabular Cup System (K972596) DEVICE DESCRIPTI…
Depuy, Inc.1996—
*K955884Coordinate Revision Knee System
Summary page 1
…Polyethylene Posterior Stabilized Tibial Tray (K943299) (DePuy) AMK Congruency Posterior Stabilized Insert (K954684) (DePuy) Coordinate II (Ultra) Knee Revision System (K955884) (DePuy) Duraloc Acetabular Cup System (K972596) DEVICE DESCRIPTION-AND INTENDED USE: The subject DePuy AMK and Coordinate Ult…
Depuy, Inc.1996—
*K972596Depuy Duraloc Acetabular Cup System
Summary page 1
…43299) (DePuy) AMK Congruency Posterior Stabilized Insert (K954684) (DePuy) Coordinate II (Ultra) Knee Revision System (K955884) (DePuy) Duraloc Acetabular Cup System (K972596) DEVICE DESCRIPTION-AND INTENDED USE: The subject DePuy AMK and Coordinate Ultra cross-linked polyethylene tibial inserts and t…
Depuy, Inc.1997—

Also cleared against K864671: 2 other devices →

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?

  • None of the 6 ancestors has a recall.
  • 2 other devices also cite its predicate K864671.

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 DePuy AMK and Coordinate Ultra Cross-Linked Polyethylene Inserts and Trays are to be used with the currently marketed AMK Total Knee System and/or the Coordinate Ultra Knee Revision System components.

The DePuy AMK Total Knee System and Coordinate Ultra Knee Revision System are intended to be used in cemented tricompartmental total knee arthroplasty to replace severely disabled or painful joints resulting from osteoarthritis or post-traumatic arthritis, joints with correctable varus or valgus deformity, and joints with failed previous surgeries where pain, deformity or dysfunction persist.

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 K864671

2 other devices cite the same predicate.

  • K100981United Stem, Psa TypeUnited Orthopedic Corp. · 2010
  • K991106P.F.C. Sigma Porous Modular Keel Tibial TrayDePuy Orthopaedics, Inc. · 1999

More from DePuy Orthopaedics, Inc.

361 FDA decisions under this applicant name. See the company

  • P070026/S129Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S130CERAMAX Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S128CERAMAX® Ceramic Total Hip SystemDePuy Orthopaedics, Inc. · 2026
  • P070026/S127Ceramax Ceramic Hip SystemDePuy Orthopaedics, Inc. · 2026
  • K252887DePuy ATTUNE™ Knee SystemDePuy Orthopaedics, Inc. · 2026

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/K982585 · printed Nov 5, 2026

Cite this page

510(k) Report. “K982585: Depuy Amk Total Knee System Depuy Coordinate Ultra Knee Revision System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982585

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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