510(k) Report

510(k) · Cleared

Recalled · Class II · 2018

Darwin Knee System (TC3)

K952830510(k) TraditionalCleared Jan 18, 1996212-day reviewClass II21 CFR 888.3560Recalls 8

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Johnson & Johnson Professionals, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Jan 18, 1996 after a 212-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 49 later devices descend from it. It has been recalled 8 times.

Decided
Jan 18, 1996
Review
212 days
Class
Class II
Product code
JWH
Recalls
8
Predicates
0

49 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2016: 1 descendant cleared2024: 4 descendants cleared2020: 4 descendants cleared2006: 1 descendant cleared2012: 3 descendants cleared2019: 5 descendants cleared2013: 2 descendants cleared2021: 8 descendants cleared2015: 1 descendant cleared2026: 3 descendants cleared2022: 3 descendants cleared2023: 6 descendants cleared2018: 3 descendants cleared2025: 4 descendants cleared2017: 1 descendant cleared1995200020052010201520202025
  1. This deviceK952830 Darwin Knee System (TC3)Johnson & Johnson Professionals, Inc. · 1996
  2. Descendant · cites it directly · 36 of its ownK060515 Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006
  3. Descendant · cites it directly · 14 of its ownK201023 iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020
  4. Descendant · 2 generations on · 14 of its ownK110404 Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · Recalled
  5. Descendant · 2 generations on · 12 of its ownK203447 iTotal Identity Cruciate Retaining (CR) Total Knee Replacement…Conformis, Inc. · 2020
  6. Descendant · 2 generations on · 10 of its ownK210191 Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · Recalled

Showing 5 of 49 descendants. See all descendants

Descendants cleared per year

2006: 12012: 32013: 22015: 12016: 12017: 12018: 32019: 52020: 42021: 82022: 32023: 62024: 42025: 42026: 3
2006high 8 (2021) · low 0 (2007)2026

Most influential descendants

Showing 5 of 49 · See all
  • K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc. · 2006 · cites it directly36descendants
  • K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc. · 2020 · cites it directly14descendants
  • K110404Eaum Total Knee SystemCorentec Co., Ltd. · 2012 · 2 generations on14descendants
  • K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity…Conformis, Inc. · 2020 · 2 generations on12descendants
  • K210191Identity Imprint Knee Replacement SystemConformis, Inc. · 2021 · 2 generations on10descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K952830Darwin Knee System (TC3)Johnson & Johnson Professionals, Inc.1996—
+1K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.2006—
+1K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.2020—
+2K110404Eaum Total Knee SystemCorentec Co., Ltd.20122
+2K203447iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal…Conformis, Inc.2020—
+2K210191Identity Imprint Knee Replacement SystemConformis, Inc.20211

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
201230
201320
201510
201610
201710
201830
201950
202040
202180
202230
202360
202440
202540
202630
FIG. 1 — Lineage of K952830, 1996–2026Source: 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
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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? (49)

See all 49

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

NumberDeviceApplicantDecidedDescendants
K060515Depuy PFC Sigma Knee ProsthesisDePuy Orthopaedics, Inc.200636
K201023iTotal® Identity Posterior Stabilized Knee Replacement SystemConformis, Inc.202014
K160700ATTUNE Revision Knee SystemDepuy (Ireland)20166
K112891Apex Revision Knee SystemsOmni Life Science, Inc.20125
K182301PFC SIGMA Knee SystemDePuy Orthopaedics, Inc.20191
K241000ATTUNE™ Revision Knee System; DePuy Knee Prosthesis System Universal Stem Extensions and…Depuy Ireland UC20240

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

Recalls of this device

DateClassRecallRoot causeReason
Jul 18, 2018Class IIZ-2949-2018Employee errorThis unit may be missing the screw/collet Assembly
Sep 27, 2007Not classifiedZ-0398-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0399-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0400-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0396-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0397-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Sep 27, 2007Not classifiedZ-0401-2008Packaging process controlAn incomplete seal on the inner pouch allows exposure to oxygen, which may result in oxidation and would affect long-term performance of the implant.
Dec 22, 2003Not classifiedZ-1369-04OtherThe collar was incorrectly etched for the R (right) and L (Left) orientation

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K060515 (DePuy Orthopaedics, Inc., 2006) has gone furthest, with 36 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 Johnson & Johnson Professionals, Inc.

206 FDA decisions under this applicant name. See the company

  • K992173Siphonguard CSF Control DeviceJohnson & Johnson Professionals, Inc. · 2000
  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  • K991222Codman Microsensor Ventricular Catheter KitJohnson & Johnson Professionals, Inc. · 1999
  • K982379Sundt Slim-Line Aneurysm Clip ApplierJohnson & Johnson Professionals, Inc. · 1998
  • K982812G2 Total Hip System Femoral Stem (11/13 Taper)Johnson & Johnson Professionals, Inc. · 1998

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/K952830 · printed Nov 4, 2026

Cite this page

510(k) Report. “K952830: Darwin Knee System (TC3).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K952830

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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