510(k) · Cleared
Recalled · 2008Triathlon PKR System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Cleared on Oct 9, 2007 as substantially equivalent to K031729 (Howmedica Osteonics Corp., 2003) and 8 other predicates after a 92-day review. Its family tree reaches back 3 generations to 2004. 25 later devices descend from it. It has been recalled once.
- Decided
- Oct 9, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- HRY
- Recalls
- 1
- Predicates
- 9
Its longest line of descent runs back 3 generations to K040267 (2004). 16 ancestors in all, the oldest K896856 (1990). 25 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK040267 Triathlon Cruciate Retaining (CR) Total KneeHowmedica Osteonics Corp. · 2004 · Recalled
- 2 generations backK042883 Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertHowmedica Osteonics Corp. · 2004
- 1 generation backK063423 Triathlon CS (Condylar Stabilizing) Lipped InsertHowmedica Osteonics · 2007
- This deviceK071881 Triathlon PKR SystemHowmedica Osteonics Corp. · 2007
- Descendant · cites it directly · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- Descendant · 2 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- Descendant · 2 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- Descendant · 2 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
- Descendant · 2 generations on · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · cites it directly24descendants
- K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 2 generations on14descendants
- K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 2 generations on11descendants
- K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
- K223528Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040267 | Triathlon Cruciate Retaining (CR) Total Knee | Howmedica Osteonics Corp. | 2004 | 1 |
| −2 | K042883 | Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert | Howmedica Osteonics Corp. | 2004 | — |
| −1 | K063423 | Triathlon CS (Condylar Stabilizing) Lipped Insert | Howmedica Osteonics | 2007 | — |
| 0 (this device) | K071881 | Triathlon PKR System | Howmedica Osteonics Corp. | 2007 | — |
| +1 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| +2 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| +2 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| +2 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
| +2 | K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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 HRY? 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 HRY device
- #1 K193549 SIGMA High Performance (HP) Partial Knee Systemscore 0.4 · 5 generations · no Class I recall
What was it cleared against? (9)
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…te that the components from these systems are compatible when used for femnorotibial replacement. Examples of predicate knee systems, include the Triathlon® Knee System (K03 1729, K040267) and X3® UHMWPE Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K9… | 2003 |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 1…e components from these systems are compatible when used for femnorotibial replacement. Examples of predicate knee systems, include the Triathlon® Knee System (K03 1729, K040267) and X3® UHMWPE Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K… | 2004 |
| * | K051146 | Triathlon Knee System | 2005 |
| * | K063423 | Triathlon CS (Condylar Stabilizing) Lipped InsertSummary page 1…eplacement. Examples of predicate knee systems, include the Triathlon® Knee System (K03 1729, K040267) and X3® UHMWPE Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K91 1373) and… | 2007 |
| * | K992287 | First Step Unicompartmental Knee SystemSummary page 1…clude the Triathlon® Knee System (K03 1729, K040267) and X3® UHMWPE Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K91 1373) and the UJNIXTM Unicompartmental Knee System (K92301 I… | 1999 |
| * | K033769 | Eius Unicompartmental Knee SystemSummary page 1…Triathlon® Knee System (K03 1729, K040267) and X3® UHMWPE Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K91 1373) and the UJNIXTM Unicompartmental Knee System (K92301 I.) Based u… | 2004 |
| * | K896856 | Mod-ML Unicompartmental Knee ProsthesisSummary page 1…MWPE Tibial Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K91 1373) and the UJNIXTM Unicompartmental Knee System (K92301 I.) Based upon the mechanical testing, the Triathlon® PKR System… | 1990 |
| * | K911373 | Osteonics Ion Implant Mod-ML Uniknee Femoral CompSummary page 1…l Inserts and: Patellar Components (KO5I1146 & K063423), the EIUS® Unicompartmental Knee System (K992287 & K033769), the SCR® Unicompartmental Knee Prosthesis (K896856 & K91 1373) and the UJNIXTM Unicompartmental Knee System (K92301 I.) Based upon the mechanical testing, the Triathlon® PKR System is substan… | 1991 |
| * | K923011 | Osteonics Unix Unicompartmental | 1993 |
What descends from it? (25)
See all 253 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2008 | Not classified | Z-0869-2009 | Labeling mix-ups | Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 6 of the 16 ancestors have a recall of any class.
- Of its descendants, K172326 (Stryker Orthopaedics, 2017) has gone furthest, with 24 descendants of its own.
- 14 other devices also cite its predicate K031729.
How does its category compare?
All HRY devicesHRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, 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 · HRY
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · HRY
138in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRY
3in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRY
290in 2025
MAUDE reports naming product code HRY, 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 | 3 | 92 | 1 | 263 |
| 2008 | 3 | 138 | 1 | 285 |
| 2009 | 0 | — | 0 | 249 |
| 2010 | 1 | — | 0 | 180 |
| 2011 | 1 | — | 1 | 155 |
| 2012 | 1 | — | 0 | 137 |
| 2013 | 1 | — | 1 | 383 |
| 2014 | 1 | — | 0 | 305 |
| 2015 | 1 | — | 0 | 345 |
| 2016 | 1 | — | 1 | 343 |
| 2017 | 0 | — | 0 | 402 |
| 2018 | 0 | — | 0 | 613 |
| 2019 | 1 | — | 0 | 367 |
| 2020 | 1 | — | 1 | 1,054 |
| 2021 | 0 | — | 1 | 1,218 |
| 2022 | 0 | — | 3 | 840 |
| 2023 | 0 | — | 0 | 396 |
| 2024 | 0 | — | 0 | 430 |
| 2025 | 0 | — | 0 | 290 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071881: Triathlon PKR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071881
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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