510(k) · Cleared
Recalled · Class II · 2014Triathlon TS 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 Jun 1, 2007 as substantially equivalent to K973164 (Howmedica Corp., 1997) and 3 other predicates after a 142-day review. Its family tree reaches back 2 generations to 2003. 64 later devices descend from it. It has been recalled 13 times.
- Decided
- Jun 1, 2007
- Review
- 142 days
- Class
- Class II
- Product code
- JWH
- Recalls
- 13
- Predicates
- 4
Its longest line of descent runs back 2 generations to K031729 (2003). 4 ancestors in all, the oldest K973164 (1997). 64 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
- 1 generation backK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
- This deviceK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
- Descendant · cites it directly · 35 of its ownK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 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 · cites it directly · 27 of its ownK140942 Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014
- 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 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K072221Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · cites it directly35descendants
- 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
- K140942Klassic Knee Tibial Stem ExtensionTotal Joint Orthopedics, Inc. · 2014 · cites it directly27descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee System | Howmedica Osteonics Corp. | 2003 | 3 |
| −1 | K042993 | Triathlon Posteriorly Stabilized (PS) Femoral Component | Howmedica Osteonics Corp. | 2005 | 1 |
| 0 (this device) | K070095 | Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | — |
| +1 | K072221 | Modification to Triathlon TS Knee System | Howmedica Osteonics Corp. | 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 |
| +1 | K140942 | Klassic Knee Tibial Stem Extension | Total Joint Orthopedics, Inc. | 2014 | — |
| +1 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 7 | 0 |
| 2022 | 5 | 0 |
| 2023 | 11 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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? (4)
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 |
|---|---|---|---|
| * | K973164 | Howmedica Total Stabilizer Knee ComponentsSummary page 2…quivalence of the Triathlon TS total knee system is based on similarities in intended use, design and sterilization to the Howmedica Total Stabilizing Total Knee System (K973164, cleared August 22, 1997), Triathlon PS Knee System (K031729, cleared September 2, 2003 and K042993 cleared January 12, 2005) and… | 1997 |
| * | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee SystemSummary page 2…similarities in intended use, design and sterilization to the Howmedica Total Stabilizing Total Knee System (K973164, cleared August 22, 1997), Triathlon PS Knee System (K031729, cleared September 2, 2003 and K042993 cleared January 12, 2005) and the Triathlon® Total Knee System (K053514, cleared January 2… | 2003 |
| * | K042993 | Triathlon Posteriorly Stabilized (PS) Femoral ComponentSummary page 2…d sterilization to the Howmedica Total Stabilizing Total Knee System (K973164, cleared August 22, 1997), Triathlon PS Knee System (K031729, cleared September 2, 2003 and K042993 cleared January 12, 2005) and the Triathlon® Total Knee System (K053514, cleared January 26, 2006). DEPARTMEN… | 2005 |
| * | K053514 | Triathlon Total Knee SystemSummary page 2…73164, cleared August 22, 1997), Triathlon PS Knee System (K031729, cleared September 2, 2003 and K042993 cleared January 12, 2005) and the Triathlon® Total Knee System (K053514, cleared January 26, 2006). DEPARTMENT OF HEALTH & HUMAN SERVICES Pu… | 2006 |
What descends from it? (64)
See all 648 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072221 | Modification to Triathlon TS Knee System | 2007 | 35 |
| K141056 | Triathlon Knee System Posterior Stabilized Components | 2014 | 28 |
| K140942 | Klassic Knee Tibial Stem Extension | 2014 | 27 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 | 24 |
| K223528 | Triathlon® Hinge Knee System | 2023 | 4 |
| K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | 2023 | 3 |
| K230537 | Klassic Knee Revision System | 2023 | 2 |
| K190991 | Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment | 2019 | 0 |
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. |
| Mar 25, 2013 | Class II | Z-1370-2013 | Software design | Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the… |
| Dec 10, 2009 | Not classified | Z-0759-2010 | Nonconforming Material/Component | Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension. |
| Dec 10, 2009 | Not classified | Z-0760-2010 | Nonconforming Material/Component | Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension. |
| Dec 10, 2009 | Not classified | Z-0761-2010 | Nonconforming Material/Component | Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension. |
| Dec 10, 2009 | Not classified | Z-0757-2010 | Nonconforming Material/Component | Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension. |
| Dec 10, 2009 | Not classified | Z-0758-2010 | Nonconforming Material/Component | Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension. |
| Apr 16, 2009 | Not classified | Z-1607-2009 | Process control | Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool. |
| Apr 16, 2009 | Not classified | Z-1608-2009 | Process control | Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool. |
| Apr 16, 2009 | Not classified | Z-1609-2009 | Process control | Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool. |
| Apr 16, 2009 | Not classified | Z-1610-2009 | Process control | Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool. |
| Nov 13, 2008 | Not classified | Z-0890-2009 | Packaging | Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices. |
| Jul 31, 2007 | Not classified | Z-1231-2007 | Other | Stabilizer posts, packaged with the Triathlon TS Plus Tibial inserts have a specification anomaly related to length, resulting in a potential for the post to slightly protrude above the top surface of the plastic post. |
The 5 latest of 13 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 1 company; a new generation was cleared every 2.4 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K072221 (Howmedica Osteonics Corp., 2007) has gone furthest, with 35 descendants of its own.
- 1 other device also cites its predicate K973164.
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. 2007, this device’s year, is highlighted.
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?
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 (215 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 unsuccessfiul knee replacement or other procedure.
· Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques.
Additional Indicationsfor PosteriorStabilized (PS)and Total Stabilizer (TS) Components:
· Ligamentous instability requiring implant bearing surface geometries with increased constraint.
* Absent or non-functioning posterior cruciate ligament.
* Severe anteroposterior instability of the knee joint.
Additional Indicationsfor Total Stabilizer (IS) Components:
- Severe instability of the knee secondary to compromised collateral ligament integrity or function.
Indicationsfor Bone Augments:
* Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
· Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
* Salvage of previous unsuccessful total knee replacement or other surgical procedure, accompanied by bone loss.
The Triathlon TS Total Knee System components are intended for cemented use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070095: Triathlon TS Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070095
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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