510(k) · Cleared
Recalled · 2010Triathlon Posteriorly Stabilized (PS) Total Knee System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 2, 2003 after a 90-day review. The FDA summary names its predicate without a number. 109 later devices descend from it. It has been recalled 3 times.
- Decided
- Sep 2, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 3
- Predicates
- 0
109 later devices descend from it, 15 citing it directly.
- This deviceK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003
- Descendant · cites it directly · 90 of its ownK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
- Descendant · cites it directly · 64 of its ownK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
- Descendant · 2 generations on · 54 of its ownK051380 Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005 · Recalled
- Descendant · 3 generations on · 51 of its ownK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
- Descendant · cites it directly · 48 of its ownK050539 Size 1 Triathlon Posterior Stabilized (PS) Tibial InsertHowmedica Osteonics Corp. · 2005
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K042993Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · cites it directly90descendants
- K070095Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · cites it directly64descendants
- K051380Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005 · 2 generations on54descendants
- K123486Triathlon Tritanium Tibial BaseplateStryker · 2013 · 3 generations on51descendants
- K050539Size 1 Triathlon Posterior Stabilized (PS) Tibial InsertHowmedica Osteonics Corp. · 2005 · cites it directly48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee System | Howmedica Osteonics Corp. | 2003 | — |
| +1 | K042993 | Triathlon Posteriorly Stabilized (PS) Femoral Component | Howmedica Osteonics Corp. | 2005 | 1 |
| +1 | K070095 | Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | 13 |
| +2 | K051380 | Triathlon Press-Fit Total Knee System | Howmedica Osteonics Corp. | 2005 | 1 |
| +3 | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | 7 |
| +1 | K050539 | Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert | Howmedica Osteonics Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 11 | 0 |
| 2025 | 10 | 0 |
| 2026 | 10 | 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? (5)
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 |
|---|---|---|---|
| * | — | Duracon Monolithic Stabilizer Femoral Component Named without a submission number | |
| * | — | Duracon Cruciform Tibial Baseplate Named without a submission number | |
| * | — | Duracon PS Lipped Tibial Insert Named without a submission number | |
| * | — | Scorpio Posteriorly Stabilized (PS) Total Knee System Named without a submission number | |
| * | — | Series 7000 Standard Tibial Tray Named without a submission number |
What descends from it? (109)
See all 10915 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042993 | Triathlon Posteriorly Stabilized (PS) Femoral Component | 2005 | 90 |
| K070095 | Triathlon TS Knee System | 2007 | 64 |
| K050539 | Size 1 Triathlon Posterior Stabilized (PS) Tibial Insert | 2005 | 48 |
| K063423 | Triathlon CS (Condylar Stabilizing) Lipped Insert | 2007 | 40 |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon… | 2013 | 33 |
| K141056 | Triathlon Knee System Posterior Stabilized Components | 2014 | 28 |
| K071881 | Triathlon PKR System | 2007 | 25 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 | 24 |
| K173849 | Triathlon Total Knee System | 2018 | 14 |
| K190402 | Triathlon Total Knee System-Additional Components | 2019 | 11 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 22, 2010 | Not classified | Z-1095-2011 | Incorrect or no expiration date | Stryker Orthopaedics has become aware that the labels on the Triathlon Distal Femoral Fixation Pegs contain an incorrect expiration date of January 2015 (2015-1) when the actual expiration date should read June 2014 (2014-6). |
| Sep 1, 2009 | Not classified | Z-2334-2010 | Mixed-up of materials/components | A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP. |
| Feb 17, 2006 | Not classified | Z-0910-2010 | Process design | Stryker Orthopaedics became aware of a potential anomaly related to the packaging process of referenced lots of X# polyethylene used on Scorpio, Triathlon and Trident inserts. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K042993 (Howmedica Osteonics Corp., 2005) has gone furthest, with 90 descendants of its own.
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.
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?
The Triathlon PS Total Knee system is comprised of femoral components, tibial trays, and tibial inserts that are intended to be used with the patellar components of the Duracon system in primary and revision total knee arthroplasty. The Triathlon PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. Specific indications and contraindications for the Triathlon PS Total Knee…
Read the full statement (194 words)
The Triathlon PS Total Knee system is comprised of femoral components, tibial trays, and tibial inserts that are intended to be used with the patellar components of the Duracon system in primary and revision total knee arthroplasty. The Triathlon PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. Specific indications and contraindications for the Triathlon PS Total Knee System are listed below:
Indications:
Painful, disabling joint disease of the knee resulting from: noninflammatory degenerative joint disease (including osteoarthritis, traumatic arthritis or avascular necrosis) or, rheumatoid 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 Indications for Posterior Stabilized Components:
Ligamentous instability requiring implant bearing surface geometries with increased constraint.
Absent or non-functioning posterior cruciate ligament.
The Triathlon PS Femoral Component and the Triathlon Primary Cemented Tibial Baseplate are intended to be implanted using bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031729 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031729: Triathlon Posteriorly Stabilized (PS) Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031729
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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