510(k) · Cleared
Recalled · Class II · 2014Triathlon Posteriorly Stabilized (PS) Femoral Component
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 Jan 12, 2005 as substantially equivalent to K031729 (Howmedica Osteonics Corp., 2003) after a 72-day review. Its family tree reaches back 1 generation to 2003. 90 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2005
- Review
- 72 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K031729 (2003). 90 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
- This deviceK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 64 of its ownK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
- Descendant · cites it directly · 54 of its ownK051380 Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005 · Recalled
- Descendant · 2 generations on · 51 of its ownK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
- Descendant · 3 generations on · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- Descendant · 2 generations on · 35 of its ownK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
Showing 5 of 90 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 90 · See all- K070095Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · cites it directly64descendants
- K051380Triathlon Press-Fit Total Knee SystemHowmedica Osteonics Corp. · 2005 · cites it directly54descendants
- K123486Triathlon Tritanium Tibial BaseplateStryker · 2013 · 2 generations on51descendants
- K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · 3 generations on38descendants
- K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · 2 generations on35descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee System | Howmedica Osteonics Corp. | 2003 | 3 |
| 0 (this device) | K042993 | Triathlon Posteriorly Stabilized (PS) Femoral Component | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K070095 | Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | 13 |
| +1 | K051380 | Triathlon Press-Fit Total Knee System | Howmedica Osteonics Corp. | 2005 | 1 |
| +2 | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | 7 |
| +3 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| +2 | K072221 | Modification to Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 13 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 8 | 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? (1)
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 |
|---|---|---|---|
| * | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee SystemSummary page 1…lymer It is the intention of Howmedica Osteonics Corp. to modify the design of the TriathlonTM Posteriorly Stabilized (PS) Femoral Component (previously released under K031729) to improve component manufacturability. The design change for the Triathlon TM PS Femoral Component involves a removal of mate… | 2003 |
What descends from it? (90)
See all 907 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070095 | Triathlon TS Knee System | 2007 | 64 |
| K051380 | Triathlon Press-Fit Total Knee System | 2005 | 54 |
| K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon… | 2013 | 33 |
| K141056 | Triathlon Knee System Posterior Stabilized Components | 2014 | 28 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 | 24 |
| K190402 | Triathlon Total Knee System-Additional Components | 2019 | 11 |
| K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component | 2023 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 15, 2014 | Class II | Z-1635-2015 | Under Investigation by firm | The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Femoral Component is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty. 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…
Read the full statement (132 words)
The Triathlon™ PS Femoral Component is intended to be used with Triathlon™ PS tibial inserts, Triathlon™ Primary Cemented Tibial Tray, and Triathlon™ and/or Duracon® patellar components in primary or revision cemented total knee arthroplasty.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042993 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042993: Triathlon Posteriorly Stabilized (PS) Femoral Component.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042993
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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