510(k) · Cleared
ClearedTriathlon Total Knee System-Additional Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Aug 22, 2019 as substantially equivalent to K040267 (Howmedica Osteonics Corp., 2004) and 8 other predicates after a 184-day review. Its family tree reaches back 11 generations to 1994. 11 later devices descend from it.
- Decided
- Aug 22, 2019
- Review
- 184 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 11 generations to K943462 (1994). 86 ancestors in all, the oldest K880155 (1988). 11 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 7 generations between
- 3 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 2 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- 1 generation backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- This deviceK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- Descendant · cites it directly · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 3 of its ownK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
- Descendant · cites it directly · 3 of its ownK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- Descendant · cites it directly · 2 of its ownK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK221850 GMK 3D Metal Tibial TrayMedacta International S.A. · 2022
Show all 11 generations
- Root · 11 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 10 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 9 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 8 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 7 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 6 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 5 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 4 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 3 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 2 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- 1 generation backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- This deviceK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · cites it directly4descendants
- K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 2 generations on3descendants
- K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · cites it directly3descendants
- K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020 · cites it directly2descendants
- K221850GMK 3D Metal Tibial TrayMedacta International S.A. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −10 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −9 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −8 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −7 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −6 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −5 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −4 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| −3 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| −2 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| −1 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| 0 (this device) | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| +1 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
| +1 | K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| +1 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020 | — |
| +2 | K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 3 | 0 |
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 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (9)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 6…ented prosthesis (21 CFR 888.3560) MBH, JWH Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Cruciate Retaining (CR) Femoral Component — K040267, K141056, K172326 Triathlon Posterior Stabilizing (PS) Femoral Component — K042993, K141056, K172326 Triathlon Primary Cemented T… | 2004 |
| * | K141056 | Triathlon Knee System Posterior Stabilized ComponentsSummary page 6…sthesis (21 CFR 888.3560) MBH, JWH Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Cruciate Retaining (CR) Femoral Component — K040267, K141056, K172326 Triathlon Posterior Stabilizing (PS) Femoral Component — K042993, K141056, K172326 Triathlon Primary Cemented Tibial Bas… | 2014 |
| * | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemSummary page 6…21 CFR 888.3560) MBH, JWH Legally Marketed Device to Which Substantial Equivalence is Claimed: Triathlon Cruciate Retaining (CR) Femoral Component — K040267, K141056, K172326 Triathlon Posterior Stabilizing (PS) Femoral Component — K042993, K141056, K172326 Triathlon Primary Cemented Tibial Baseplate —… | 2017 |
| * | K042993 | Triathlon Posteriorly Stabilized (PS) Femoral ComponentSummary page 6…tantial Equivalence is Claimed: Triathlon Cruciate Retaining (CR) Femoral Component — K040267, K141056, K172326 Triathlon Posterior Stabilizing (PS) Femoral Component — K042993, K141056, K172326 Triathlon Primary Cemented Tibial Baseplate — K031729, K141056, K172326 Triathlon Tritanium Tibial Baseplate —… | 2005 |
| * | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee SystemSummary page 6…al Component — K040267, K141056, K172326 Triathlon Posterior Stabilizing (PS) Femoral Component — K042993, K141056, K172326 Triathlon Primary Cemented Tibial Baseplate — K031729, K141056, K172326 Triathlon Tritanium Tibial Baseplate — K123486, K141056, K172326 Triathlon X3 ETO Tibial Inserts (CR, Condyla… | 2003 |
| * | K123486 | Triathlon Tritanium Tibial BaseplateSummary page 6…lizing (PS) Femoral Component — K042993, K141056, K172326 Triathlon Primary Cemented Tibial Baseplate — K031729, K141056, K172326 Triathlon Tritanium Tibial Baseplate — K123486, K141056, K172326 Triathlon X3 ETO Tibial Inserts (CR, Condylar Stabilizing [CS], and PS) — K172634, K173849 Triathlon N2Vac Tib… | 2013 |
| * | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsSummary page 6…— K031729, K141056, K172326 Triathlon Tritanium Tibial Baseplate — K123486, K141056, K172326 Triathlon X3 ETO Tibial Inserts (CR, Condylar Stabilizing [CS], and PS) — K172634, K173849 Triathlon N2Vac Tibial Inserts (CR, CS, and PS) — K031729, K040267, K063423, K141056, K172326, K173849 Device Descript… | 2017 |
| * | K173849 | Triathlon Total Knee SystemSummary page 6…9, K141056, K172326 Triathlon Tritanium Tibial Baseplate — K123486, K141056, K172326 Triathlon X3 ETO Tibial Inserts (CR, Condylar Stabilizing [CS], and PS) — K172634, K173849 Triathlon N2Vac Tibial Inserts (CR, CS, and PS) — K031729, K040267, K063423, K141056, K172326, K173849 Device Description: The… | 2018 |
| * | K063423 | Triathlon CS (Condylar Stabilizing) Lipped InsertSummary page 6…, K172326 Triathlon X3 ETO Tibial Inserts (CR, Condylar Stabilizing [CS], and PS) — K172634, K173849 Triathlon N2Vac Tibial Inserts (CR, CS, and PS) — K031729, K040267, K063423, K141056, K172326, K173849 Device Description: The additional components being added to the Triathlon Total Knee System are: e… | 2007 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 25 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 48 of the 86 ancestors have a recall of any class.
- Of its descendants, K230952 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2023) has gone furthest, with 4 descendants of its own.
- 16 other devices also cite its predicate K040267.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
General Total Knee Arthroplasty (TKR) Indications: Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis. Post-traumatic loss of knee joint configuration and function. Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function…
Read the full statement (389 words)
General Total Knee Arthroplasty (TKR) Indications:
Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis, or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.
Post-traumatic loss of knee joint configuration and function.
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability.
Revision of previous unsuccessful knee replacement or other procedure.
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.
Severe anteroposterior instability of the knee joint.
Additional Indications for Total Stabilizer (TS) Components:
Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indications for Bone Augments:
Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments:
Severe degeneration or trauma requiring extensive resection and replacement
Femoral and Tibial bone voids
Metaphyseal reconstruction
The Triathlon TS Cone Augment components are intended for cemented or cementless use.
General Total Knee Arthroplasty (TKR) Indications:
Painful, disabling joint disease of the knee resulting from: non-inflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) rheumatoid arthritis or post-traumatic arthritis
Post-traumatic loss of knee joint configuration and function
Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability
Revision of previous unsuccessful knee replacement or other procedure
Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
Additional General Total Knee Arthroplasty (TKR) Indications specific to the PS implant:
Ligamentous instability requiring implant bearing surface geometries with increased constraint
Absent or non-functioning posterior cruciate ligament
Severe anteroposterior instability of the knee joint
The Triathlon Tritanium Tibial Baseplates are indicated for both cemented and uncemented use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K190402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190402: Triathlon Total Knee System-Additional Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190402
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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