510(k) · Cleared
ClearedTriathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Feb 18, 2026 as substantially equivalent to K242831 (Howmedica Osteonics Corp., Dba Stryker Orthopaedics, 2024) and 1 other predicate after a 91-day review. Its family tree reaches back 14 generations to 1994.
- Decided
- Feb 18, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943462 (1994). 253 ancestors in all, the oldest K810258 (1981). No later device cites it as a predicate yet.
- Root · 14 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 10 generations between
- 3 generations backK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- 2 generations backK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- 1 generation backK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
- This deviceK253637 Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
Show all 14 generations
- Root · 14 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 13 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 12 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 11 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 10 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 9 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 8 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 7 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 6 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 5 generations backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- 4 generations backK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- 3 generations backK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- 2 generations backK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- 1 generation backK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
- This deviceK253637 Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −13 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −12 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −11 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −10 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −9 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −8 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −7 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| −6 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| −5 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| −4 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| −3 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| −2 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| −1 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
| 0 (this device) | K253637 | Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1983 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 3 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 14 | 0 |
| 1995 | 11 | 0 |
| 1996 | 13 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 8 | 0 |
| 2000 | 10 | 0 |
| 2001 | 11 | 0 |
| 2002 | 9 | 0 |
| 2003 | 19 | 0 |
| 2004 | 15 | 0 |
| 2005 | 19 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 8 | 0 |
| 2011 | 1 | 0 |
| 2012 | 8 | 0 |
| 2013 | 5 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2024 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Summary page 6…3637 Page 2 of 4 Legally Marketed Primary and Additional Predicate Devices to Which Substantial Equivalence is Claimed: • Triathlon® X3® CS Tibial Bearing Insert - K242831 (Primary Predicate) • Triathlon® X3® PS Tibial Bearing Insert - K242831 (Additional Predicate) • Persona® Medial Congru… | 2024 |
| * | K243293 | Zimmer® Persona® Personalized Knee SystemSummary page 6…ng Insert - K242831 (Primary Predicate) • Triathlon® X3® PS Tibial Bearing Insert - K242831 (Additional Predicate) • Persona® Medial Congruent Bearing Insert - K243293 (Additional Predicate) Legally Marketed Reference Devices Used to Support Substantial Equivalence: • Triathlon® CS Tibial… | 2024 |
| † | K250989 | Stryker and Serf hip devices | 2025 |
| † | K240418 | Stryker Orthopaedics Hip Systems Labeling Update | 2024 |
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 32 years and passes through 7 companies; a new generation was cleared every 1.5 years on median.
- 101 of the 253 ancestors have a recall of any class.
- 2 other devices also cite its predicate K242831.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 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 (106 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.
* Ligamentous instability requiring implant bearing surface geometries with increased constraint.
* Absent or non-functioning posterior cruciate ligament.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K253637: Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K253637
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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