510(k) Report

510(k) · Cleared

Cleared

Duracon CS Lipped Extra Small Tibial Insert

K023724510(k) TraditionalCleared Feb 3, 200390-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

Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Cleared on Feb 3, 2003 after a 90-day review. The FDA summary names no predicate by number. 41 later devices descend from it.

Decided
Feb 3, 2003
Review
90 days
Class
Class II
Product code
JWH
Recalls
None
Predicates
0

41 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 2 descendants cleared2014: 2 descendants cleared2019: 4 descendants cleared2013: 2 descendants cleared2017: 2 descendants cleared2018: 3 descendants cleared2026: 4 descendants cleared2024: 5 descendants cleared2015: 1 descendant cleared2025: 3 descendants cleared2023: 3 descendants cleared2020: 6 descendants cleared2022: 2 descendants cleared2021: 2 descendants cleared200020052010201520202025
  1. This deviceK023724 Duracon CS Lipped Extra Small Tibial InsertHowmedica Osteonics Corp. · 2003
  2. Descendant · cites it directly · 40 of its ownK063423 Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007
  3. Descendant · 2 generations on · 33 of its ownK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
  4. Descendant · 2 generations on · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
  5. Descendant · 2 generations on · 25 of its ownK071881 Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · Recalled
  6. Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled

Showing 5 of 41 descendants. See all descendants

Descendants cleared per year

2007: 22013: 22014: 22015: 12017: 22018: 32019: 42020: 62021: 22022: 22023: 32024: 52025: 32026: 4
2007high 6 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 41 · See all
  • K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007 · cites it directly40descendants
  • K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp. · 2013 · 2 generations on33descendants
  • K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · 2 generations on28descendants
  • K071881Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · 2 generations on25descendants
  • K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023724Duracon CS Lipped Extra Small Tibial InsertHowmedica Osteonics Corp.2003—
+1K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics2007—
+2K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp.2013—
+2K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics201411
+2K071881Triathlon PKR SystemHowmedica Osteonics Corp.20071
+2K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics20171

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200720
201320
201420
201510
201720
201830
201940
202060
202120
202220
202330
202450
202530
202640
FIG. 1 — Lineage of K023724, 2003–2026Source: 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), 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?

The FDA summary names no predicate by number.

What descends from it? (41)

See all 41

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics200740

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?

  • Of its descendants, K063423 (Howmedica Osteonics, 2007) has gone furthest, with 40 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—

What is it indicated for?

The Duracon@CS (Condylar Stabilizing) Lipped Extra Small Tibial Insert is intended to be used with Duracon@Extra Small Universal and Cruciform tibial baseplates, Durac.on@ Cruciate Retaining femoral components and Duraconm patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the…

Read the full statement (256 words)

The Duracon@CS (Condylar Stabilizing) Lipped Extra Small Tibial Insert is intended to be used with Duracon@Extra Small Universal and Cruciform tibial baseplates, Durac.on@ Cruciate Retaining femoral components and Duraconm patellar components as part of a total knee system in primary cemented total knee arthroplasty. These inserts are intended to be used in cases where there is destruction of the joint surfaces with or without bone deformity, where the cruciate ligaments are inadequate, not present, or cannot be preserved during the operative procedure, especially when anterior-posterior stability is impaired due to absence of the patella. The collateral ligaments should be intact if this insert is utilized. This tibial insert may also be used in situations where the posterior cruciate ligament is present - its geometry will accommodate that ligament. More specific indications and contraindications are listed below:

Indications

Noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis,

Rheumatoid arthritis,

Correction of functional deformity,

Post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and,

Irreparable Eracture of the knee

Absolute contraindications include:

Overt infection,

Distant foci of infections (which may cause hematogenous spread to the implant site),

Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram,

Skeletally immature patients

Cases where there is poor bone stock which would make the procedure unjustifiable,

Conditions presenting an increased risk of failure include:

Uncooperative patient or patient with neurological disorders who is incapable of following instructions,

Osteoporosis,

Metabolic disorders which may impair bone formation,

Osteomalacia, and

Previous arthrodesis

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K023724: Duracon CS Lipped Extra Small Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023724

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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