510(k) · Cleared
ClearedSize 1 Triathlon Cruciate Retaining (CR) Tibial Insert
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 Nov 23, 2004 as substantially equivalent to K040267 (Howmedica Osteonics Corp., 2004) after a 35-day review. Its family tree reaches back 1 generation to 2004. 48 later devices descend from it.
- Decided
- Nov 23, 2004
- Review
- 35 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K040267 (2004). 48 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK040267 Triathlon Cruciate Retaining (CR) Total KneeHowmedica Osteonics Corp. · 2004 · Recalled
- This deviceK042883 Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp. · 2004
- Descendant · cites it directly · 40 of its ownK063423 Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007
- 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 · 2 generations on · 25 of its ownK071881 Triathlon PKR SystemHowmedica Osteonics Corp. · 2007 · Recalled
- Descendant · cites it directly · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K063423Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007 · cites it directly40descendants
- 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 · 2 generations on25descendants
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K040267 | Triathlon Cruciate Retaining (CR) Total Knee | Howmedica Osteonics Corp. | 2004 | 1 |
| 0 (this device) | K042883 | Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert | Howmedica Osteonics Corp. | 2004 | — |
| +1 | K063423 | Triathlon CS (Condylar Stabilizing) Lipped Insert | Howmedica Osteonics | 2007 | — |
| +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 |
| +2 | K071881 | Triathlon PKR System | Howmedica Osteonics Corp. | 2007 | 1 |
| +1 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 4 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 7 | 0 |
| 2025 | 3 | 0 |
| 2026 | 6 | 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 |
|---|---|---|---|
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 2…ntended Use The intended use of the size one TriathlonTM Cruciate Retaining Tibial Insert is the same as that of the predicate device described in premarket notification K040267 - it is intended for use with TriathlonTM Cruciate Retaining femoral components, TriathlonTM Primary Cemented Tibial Tray, and Tr… | 2004 |
What descends from it? (48)
See all 486 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 |
| K141056 | Triathlon Knee System Posterior Stabilized Components | 2014 | 28 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 | 24 |
| K173849 | Triathlon Total Knee System | 2018 | 14 |
| K113060 | Unity Toatal Knee System | 2012 | 8 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | 2026 | 0 |
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?
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 CR Size I tibial inserts are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications are listed below: Indications: * Painful, disabling joint disease of the knee resulting from: noninflammatory…
Read the full statement (257 words)
The Triathlon CR Size I tibial inserts are intended to be used with the previously cleared Triathlon™ Primary Cemented Tibial Tray in primary or revision total knee arthroplasty. The Triathlon™ CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. Specific indications and contraindications 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.
Contraindications
* Any active or suspected latent infection in or about the knee joint.
* Distant foci of infection which may cause hematogenous spread to the implant site
* Any mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
* Bone stock compromised by disease, infection or prior implantation that cannot provide adequate support and/or fixation to the prosthesis.
* Skeletal immaturity.
* Severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
Obesity. An overweight or obese patient can produce loads on the prosthesis that can lead to failure of the fixation of the device or to failure of the device itself.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042883 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042883: Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042883
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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