510(k) Report

510(k) · Cleared

Cleared

ATTUNE All-Polyethylene Tibia

K193057510(k) TraditionalCleared Jan 30, 202090-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 Ireland UC · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 30, 2020 as substantially equivalent to K943462 (Johnson & Johnson Professionals, Inc., 1994) and 4 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1994.

Decided
Jan 30, 2020
Review
90 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
5

Its longest line of descent runs back 4 generations to K943462 (1994). 11 ancestors in all, the oldest K922620 (1992). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1997: 1 other ancestor1996: 1 other ancestor1995: 2 other ancestors2008: 1 other ancestor2003: 1 other ancestor1992: 1 other ancestorK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled×2: 2 generations cleared close together, K033272 (2004), K040166 (2004) K101433 · Depuy Attune Knee System · DePuy Orthopaedics, Inc. · 20101990199520002005201020152020
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 4 other ancestors K101433 · Depuy Attune Knee System · DePuy Orthopaedics, Inc. · 2010K040166 · Depuy Sigma XLK Tibial Inserts · DePuy Orthopaedics, Inc. · 2004K033272 · Depuy Sigma Tibial Inserts · DePuy Orthopaedics, Inc. · 2004 · recalledK943462 · Darwin Knee System · Johnson & Johnson Professionals, Inc. · 1994 · recalled0
  1. Root · 4 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
  2. 3 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
  3. 2 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
  4. 1 generation backK101433 Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
  5. This deviceK193057 ATTUNE All-Polyethylene TibiaDepuy Ireland UC · 2020
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K943462Darwin Knee SystemJohnson & Johnson Professionals, Inc.19948
−3K033272Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc.200451
−2K040166Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc.2004—
−1K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc.2010—
0 (this device)K193057ATTUNE All-Polyethylene TibiaDepuy Ireland UC2020—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199520
199610
199710
200310
200810
FIG. 1 — Lineage of K193057, 1994–2020Source: 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
*K943462Darwin Knee System
Summary page 4
…s II Classification panel 87 Orthopedics Regulation 21 CFR 888.3560 Product Code(s) JWH Legally marketed device(s) to which equivalence is claimed Darwin Knee System, K943462 Darwin Knee System (Cruciate-Substituting) Porous Coated and Non- Porous Coated, K950010 P.F.C. Cruciate Retaining Knee System…
Johnson & Johnson Professionals, Inc.19948
*K950010Darwin Knee System (Cruciate Substituting) Porous Coated and Non-Porous Coated
Summary page 4
…Legally marketed device(s) to which equivalence is claimed Darwin Knee System, K943462 Darwin Knee System (Cruciate-Substituting) Porous Coated and Non- Porous Coated, K950010 P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685 P.F.C. Sigma Knee System (Size 1.5), K971189 DePuy ATTUNE Knee Syste…
Johnson & Johnson Professionals, Inc.199516
*K961685P.F.C. Cruciate Retaining Knee System (Size 1.5)
Summary page 4
…Darwin Knee System, K943462 Darwin Knee System (Cruciate-Substituting) Porous Coated and Non- Porous Coated, K950010 P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685 P.F.C. Sigma Knee System (Size 1.5), K971189 DePuy ATTUNE Knee System, K101433 Reason for 510(k) submission This 510(k) submi…
Johnson & Johnson Professionals, Inc.19967
*K971189P.F.C. Sigma Knee System (Size 1.5)
Summary page 4
…em (Cruciate-Substituting) Porous Coated and Non- Porous Coated, K950010 P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685 P.F.C. Sigma Knee System (Size 1.5), K971189 DePuy ATTUNE Knee System, K101433 Reason for 510(k) submission This 510(k) submission is to add the ATTUNE All Polyethylene Ti…
Johnson & Johnson Professionals, Inc.1997—
*K101433Depuy Attune Knee System
Summary page 4
…oated and Non- Porous Coated, K950010 P.F.C. Cruciate Retaining Knee System (Size 1.5), K961685 P.F.C. Sigma Knee System (Size 1.5), K971189 DePuy ATTUNE Knee System, K101433 Reason for 510(k) submission This 510(k) submission is to add the ATTUNE All Polyethylene Tibia to the currently cleared ATTUNE…
DePuy Orthopaedics, Inc.2010—

Also cleared against K943462: 11 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?

  • The line of descent spans 26 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
  • 6 of the 11 ancestors have a recall of any class.
  • 11 other devices also cite its predicate K943462.

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. 2020, 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?

Candidates for total knee replacement include patients with a severely painful and/or severely disabled joint resulting

from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.

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 K943462

11 other devices cite the same predicate.

  • K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and Universal Femoral…Depuy Ireland UC · 2024
  • K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc. · 2019
  • K150496Total Knee Arthroplasty SystemResponsive Orthopedics, LLC · 201512 recalls
  • K101433Depuy Attune Knee SystemDePuy Orthopaedics, Inc. · 2010
  • K082500Depuy Sigma CR-F Femoral ComponentDePuy Orthopaedics, Inc. · 2008
  • K062654Depuy Sigma Cruciate Retaining Porocoat Femoral ComponentsDePuy Orthopaedics, Inc. · 2006

More from Depuy Ireland UC

49 FDA decisions under this applicant name. See the company

  • K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC · 2026
  • K260536Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementDepuy Ireland UC · 2026
  • K253624INHANCE™ Reverse Shoulder SystemDepuy Ireland UC · 2026
  • K253551VELYS™ Hip NavigationDepuy Ireland UC · 2026
  • K253197ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral AdaptorsDepuy Ireland UC · 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/K193057 · printed Nov 6, 2026

Cite this page

510(k) Report. “K193057: ATTUNE All-Polyethylene Tibia.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193057

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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