510(k) · Cleared
Recalled · 2008Triathlon 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 Jul 13, 2005 after a 70-day review. The FDA summary names its predicate without a number. 55 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 13, 2005
- Review
- 70 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 3
- Predicates
- 0
55 later devices descend from it, 6 citing it directly.
- This deviceK051146 Triathlon Knee SystemHowmedica Osteonics Corp. · 2005
- Descendant · cites it directly · 40 of its ownK063423 Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007
- Descendant · cites it directly · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- Descendant · 2 generations on · 33 of its ownK123166 Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants…Howmedica Osteonics Corp. · 2013
- Descendant · cites it directly · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
- Descendant · cites it directly · 25 of its ownK071881 Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · Recalled
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007 · cites it directly40descendants
- K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · cites it directly38descendants
- K123166Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon…Howmedica Osteonics Corp. · 2013 · 2 generations on33descendants
- K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · cites it directly28descendants
- K071881Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051146 | Triathlon Knee System | Howmedica Osteonics Corp. | 2005 | — |
| +1 | K063423 | Triathlon CS (Condylar Stabilizing) Lipped Insert | Howmedica Osteonics | 2007 | — |
| +1 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| +2 | K123166 | Triathlon All-Polyethylene Condylar Stabilizing (CS) Tibial Implants Triathlon… | Howmedica Osteonics Corp. | 2013 | — |
| +1 | K141056 | Triathlon Knee System Posterior Stabilized Components | Stryker Orthopaedics | 2014 | 11 |
| +1 | K071881 | Triathlon PKR System | Howmedica Osteonics Corp. | 2007 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 4 | 0 |
| 2026 | 7 | 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 |
|---|---|---|---|
| * | — | Triathlon® Tibial Inserts and Patellar Named without a submission number |
What descends from it? (55)
See all 556 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063423 | Triathlon CS (Condylar Stabilizing) Lipped Insert | 2007 | 40 |
| K132624 | Triathlon Tritanium Metal-Backed Patella | 2013 | 38 |
| 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 |
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | 2017 | 18 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2008 | Not classified | Z-1013-2009 | Labeling mix-ups | Stryker Orthopaedics became aware of a lot for lot mix-up between part numbers 5532-G-713, lot code LBD528 (Triathlon X3 Posterior Stabilized Tibial Insert, size 7-13 mm) and part 5532-G-813, lot code LBD512 (Triathlon X3 Posterior… |
| Dec 4, 2006 | Not classified | Z-0399-2007 | Other | A product mix-up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa. |
| Dec 4, 2006 | Not classified | Z-0400-2007 | Other | A product mix -up in which the labeling indicates a Triathlon X# CR Tibial Bearing Insert Size #2 - 11MM, however, the device inside the package is actually a Triathlon X3 CR Tibial Bearing insert Size # 7 - 11MM and vice versa. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K063423 (Howmedica Osteonics, 2007) has gone furthest, with 40 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® X3TM UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3TM UHMWPE Pateliar components are intended to be used with the cemented Triathlon® PS and CR femoral 'components and cemented Triathlon ® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3TM UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon®…
Read the full statement (235 words)
The Triathlon® X3TM UHMWPE Posterior Stabilized and Cruciate Retaining tibial inserts and the Triathlon® X3TM UHMWPE Pateliar components are intended to be used with the cemented Triathlon® PS and CR femoral 'components and cemented Triathlon ® Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon® X3TM UHMWPE Patellar components are intended to be used with the femoral components of the previously released Duracon® Total Knee System The Triathlon® PS Total Knee System is intended to be used in situations where the posterior cruciate ligament is absent, or cannot be preserved. The Triathlon® CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The all polyethylene Triathlon® X3TM UHMWPE Patellar components are intended for implantation with bone cement only.
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 pmximal 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/K051146 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051146: Triathlon 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/K051146
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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