510(k) · Cleared
ClearedTriathlon Total KneeSystem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Jul 10, 2020 as substantially equivalent to K172326 (Stryker Orthopaedics, 2017) and 3 other predicates after a 51-day review. Its family tree reaches back 16 generations to 1994. 3 later devices descend from it.
- Decided
- Jul 10, 2020
- Review
- 51 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 16 generations to K941847 (1994). 252 ancestors in all, the oldest K810258 (1981). 3 later devices descend from it, 2 citing it directly.
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 12 generations between
- 3 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 2 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 1 generation backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- This deviceK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- Descendant · cites it directly · 1 of its ownK221850 GMK 3D Metal Tibial TrayMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK261898 Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total…Howmedica Osteonics Corp. dba Stryker Orthopaedics · 2026
- Descendant · 2 generations on · 0 of its ownK253328 GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026
Show all 16 generations
- Root · 16 generations backK941847 5/8 Porocoat Aml Hip Porocoat Porous CoatingDepuy, Inc. · 1994
- 15 generations backK964650 TCP-Coated Porocoat Aml Femoral Hip ProsthesisDepuy, Inc. · 1997
- 14 generations backK980711 Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic…Zimmer, Inc. · 1998 · Recalled
- 13 generations backK001277 Triflange Acetabular Cup SystemDePuy Orthopaedics, Inc. · 2000
- 12 generations backK031495 Pinnacle Duofix HA Acetabular Cup ProsthesisDePuy Orthopaedics, Inc. · 2003
- 11 generations backK042344 Excia Total Hip SystemAesculap, Inc. · 2005 · Recalled
- 10 generations backK070981 Search Evolution (LC) Total Knee System (Plasmapore)Aesculap Implant Systems, Inc. · 2007
- 9 generations backK081023 Evolis Total Knee SystemMedacta International S.A. · 2008 · Recalled
- 8 generations backK090988 GMK Total Knee SystemMedacta International S.A. · 2009 · Recalled
- 7 generations backK102437 GMK Revision Knee SystemMedacta International S.A. · 2010
- 6 generations backK103170 GMK Revision Knee SC LinersMedacta International S.A. · 2011
- 5 generations backK113571 GMK Resufacing Patella Size 4Medacta International · 2012
- 4 generations backK121416 GMK SphereMedacta International · 2012
- 3 generations backK140826 GMK Sphere ExtensionMedacta International · 2014
- 2 generations backK162035 GMK SphereMedacta International S.A. · 2017
- 1 generation backK173890 GMK Sphere - Kinematic AlignmentMedacta International S.A. · 2018
- This deviceK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
Most influential descendants
Showing 3 of 3 · See all- K221850GMK 3D Metal Tibial TrayMedacta International S.A. · 2022 · cites it directly1descendant
- K261898Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee SystemHowmedica Osteonics Corp. dba Stryker Orthopaedics · 2026 · cites it directly0descendants
- K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K941847 | 5/8 Porocoat Aml Hip Porocoat Porous Coating | Depuy, Inc. | 1994 | — |
| −15 | K964650 | TCP-Coated Porocoat Aml Femoral Hip Prosthesis | Depuy, Inc. | 1997 | — |
| −14 | K980711 | Harris/Galante Porous (HGP) Hip Prosthesis with Calcicoat Ceramic Coating | Zimmer, Inc. | 1998 | 1 |
| −13 | K001277 | Triflange Acetabular Cup System | DePuy Orthopaedics, Inc. | 2000 | — |
| −12 | K031495 | Pinnacle Duofix HA Acetabular Cup Prosthesis | DePuy Orthopaedics, Inc. | 2003 | — |
| −11 | K042344 | Excia Total Hip System | Aesculap, Inc. | 2005 | 10 |
| −10 | K070981 | Search Evolution (LC) Total Knee System (Plasmapore) | Aesculap Implant Systems, Inc. | 2007 | — |
| −9 | K081023 | Evolis Total Knee System | Medacta International S.A. | 2008 | 1 |
| −8 | K090988 | GMK Total Knee System | Medacta International S.A. | 2009 | 1 |
| −7 | K102437 | GMK Revision Knee System | Medacta International S.A. | 2010 | — |
| −6 | K103170 | GMK Revision Knee SC Liners | Medacta International S.A. | 2011 | — |
| −5 | K113571 | GMK Resufacing Patella Size 4 | Medacta International | 2012 | — |
| −4 | K121416 | GMK Sphere | Medacta International | 2012 | — |
| −3 | K140826 | GMK Sphere Extension | Medacta International | 2014 | — |
| −2 | K162035 | GMK Sphere | Medacta International S.A. | 2017 | — |
| −1 | K173890 | GMK Sphere - Kinematic Alignment | Medacta International S.A. | 2018 | — |
| 0 (this device) | K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| +1 | K221850 | GMK 3D Metal Tibial Tray | Medacta International S.A. | 2022 | — |
| +1 | K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | Howmedica Osteonics Corp. dba Stryker Orthopaedics | 2026 | — |
| +2 | K253328 | GMK 3D Metal Tibial Tray Extension | Medacta International S.A. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 6 | 0 |
| 1993 | 5 | 0 |
| 1994 | 11 | 0 |
| 1995 | 13 | 0 |
| 1996 | 13 | 0 |
| 1997 | 11 | 0 |
| 1998 | 9 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 13 | 0 |
| 2002 | 15 | 0 |
| 2003 | 17 | 0 |
| 2004 | 15 | 0 |
| 2005 | 16 | 0 |
| 2006 | 11 | 0 |
| 2007 | 16 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 6 | 0 |
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2026 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemSummary page 4…Codes: JWH, MBH Legally Marketed Device to Which Substantial Equivalence is Claimed: Primary predicate: Triathlon® Total Knee System cleared most recently via K172326 and K190402 Secondary predicates: Zimmer Persona® Personalized Knee System cleared via K172524, Medacta GMK Sphere Knee cleared v… | 2017 |
| * | K190402 | Triathlon Total Knee System-Additional ComponentsSummary page 4…JWH, MBH Legally Marketed Device to Which Substantial Equivalence is Claimed: Primary predicate: Triathlon® Total Knee System cleared most recently via K172326 and K190402 Secondary predicates: Zimmer Persona® Personalized Knee System cleared via K172524, Medacta GMK Sphere Knee cleared via K173890… | 2019 |
| * | K172524 | Zimmer Persona Personalized Knee SystemSummary page 4…Primary predicate: Triathlon® Total Knee System cleared most recently via K172326 and K190402 Secondary predicates: Zimmer Persona® Personalized Knee System cleared via K172524, Medacta GMK Sphere Knee cleared via K173890 Device Description: This submission covers Mako Total Knee Application-compatible… | 2018 |
| * | K173890 | GMK Sphere - Kinematic AlignmentSummary page 4…tem cleared most recently via K172326 and K190402 Secondary predicates: Zimmer Persona® Personalized Knee System cleared via K172524, Medacta GMK Sphere Knee cleared via K173890 Device Description: This submission covers Mako Total Knee Application-compatible components of the Triathlon® Total Knee Syste… | 2018 |
What descends from it? (3)
2 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 26 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 108 of the 251 ancestors have a recall of any class.
- Of its descendants, K221850 (Medacta International S.A., 2022) has gone furthest, with 1 descendant of its own.
- 13 other devices also cite its predicate K172326.
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. 2020, 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…
Read the full statement (168 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 Tibial Baseplate and Tritanium Metal-Backed Patella 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) 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201343 · printed Nov 6, 2026
Cite this page
510(k) Report. “K201343: Triathlon Total KneeSystem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K201343
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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