510(k) · Cleared
ClearedTriathlon® Total Knee System - Triathlon® Gold Femoral Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp., Dba Stryker Orthopaedics · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Oct 24, 2025 as substantially equivalent to K051380 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 116-day review. Its family tree reaches back 10 generations to 1998.
- Decided
- Oct 24, 2025
- Review
- 116 days
- Class
- Class II
- Product code
- MBH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K982302 (1998). 149 ancestors in all, the oldest K810520 (1981). No later device cites it as a predicate yet.
- Root · 10 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 6 generations between
- 3 generations backK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- 2 generations backK163332 Apex Revision Knee SystemOmnilife Science · 2017
- 1 generation backK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- This deviceK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
Show all 10 generations
- Root · 10 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 9 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 8 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 7 generations backK053505 Regenerex Ultra Porous Construct-Femoral and Tibial Knee AugmentsBiomet Manufacturing, Inc. · 2006
- 6 generations backK080361 Regenerex Tibial ComponentsBiomet, Inc. · 2008 · Recalled
- 5 generations backK101994 Apex Knee Modular Tibia SystemOmnlife Science · 2010 · Recalled
- 4 generations backK131472 Apex Knee Modular Tibia SystemOmni Life Science, Inc. · 2013
- 3 generations backK153437 Apex Revision Knee SystemOmnilife Science · 2015 · Recalled
- 2 generations backK163332 Apex Revision Knee SystemOmnilife Science · 2017
- 1 generation backK191765 OMNI TiN Coated Apex Knee™ SystemOmni Life Science, Inc. · 2019
- This deviceK252044 Triathlon® Total Knee System - Triathlon® Gold Femoral ComponentsHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −9 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −8 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −7 | K053505 | Regenerex Ultra Porous Construct-Femoral and Tibial Knee Augments | Biomet Manufacturing, Inc. | 2006 | — |
| −6 | K080361 | Regenerex Tibial Components | Biomet, Inc. | 2008 | 1 |
| −5 | K101994 | Apex Knee Modular Tibia System | Omnlife Science | 2010 | 1 |
| −4 | K131472 | Apex Knee Modular Tibia System | Omni Life Science, Inc. | 2013 | — |
| −3 | K153437 | Apex Revision Knee System | Omnilife Science | 2015 | 1 |
| −2 | K163332 | Apex Revision Knee System | Omnilife Science | 2017 | — |
| −1 | K191765 | OMNI TiN Coated Apex Knee™ System | Omni Life Science, Inc. | 2019 | — |
| 0 (this device) | K252044 | Triathlon® Total Knee System - Triathlon® Gold Femoral Components | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 6 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 8 | 0 |
| 2001 | 6 | 0 |
| 2002 | 11 | 0 |
| 2003 | 14 | 0 |
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 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 MBH? 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 MBH device
- #1 K241597 Freedom® Total Knee System - Porous Tibial…score 19.9 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K051380 | Triathlon Press-Fit Total Knee SystemSummary page 6…K252044 Page 2 of 4 Legally Marketed Primary and Additional Predicate Devices to Which Substantial Equivalence is Claimed: • Triathlon™ Total Knee System - K051380 (Primary Predicate) • Omni TiN Coated Apex Knee™ System - K191765 (Additional predicate) Legally Marketed Reference Device… | 2005 |
| * | K191765 | OMNI TiN Coated Apex Knee™ SystemSummary page 6…dicate Devices to Which Substantial Equivalence is Claimed: • Triathlon™ Total Knee System - K051380 (Primary Predicate) • Omni TiN Coated Apex Knee™ System - K191765 (Additional predicate) Legally Marketed Reference Devices Used to Support Substantial Equivalence: • Triathlon® Tritanium… | 2019 |
| † | K123486 | Triathlon Tritanium Tibial Baseplate | 2013 |
| † | K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | 2018 |
| † | K212761 | Biocore9 Acetabular Cup System | 2022 |
| † | K963101 | B-P Hemispherical Acetabular Component | 1997 |
| † | K161569 | Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws | 2016 |
| † | K093746 | Verilast Wear Claims for the Legion Primary Knee System | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 69 of the 149 ancestors have a recall of any class.
- 7 other devices also cite its predicate K051380.
How does its category compare?
All MBH devicesMBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · MBH
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBH
98in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBH
1in 2024
Class I (5 since 2007) Class II/III not classified
Adverse event reports per year · MBH
1,561in 2025
MAUDE reports naming product code MBH, 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 | 10 | 59 | 0 | 27 |
| 2008 | 3 | 70 | 0 | 21 |
| 2009 | 3 | 209 | 2 | 89 |
| 2010 | 4 | 84 | 0 | 121 |
| 2011 | 5 | 84 | 15 | 247 |
| 2012 | 5 | 90 | 1 (1) | 370 |
| 2013 | 6 | 138 | 4 (4) | 308 |
| 2014 | 9 | 114 | 0 | 385 |
| 2015 | 8 | 100 | 0 | 955 |
| 2016 | 4 | 74 | 1 | 1,034 |
| 2017 | 4 | 115 | 9 | 1,007 |
| 2018 | 6 | 89 | 1 | 1,191 |
| 2019 | 1 | — | 1 | 1,394 |
| 2020 | 7 | 112 | 2 | 1,089 |
| 2021 | 6 | 48 | 0 | 1,539 |
| 2022 | 7 | 57 | 0 | 1,261 |
| 2023 | 6 | 94 | 2 | 1,263 |
| 2024 | 10 | 84 | 1 | 1,497 |
| 2025 | 8 | 98 | 0 | 1,561 |
| 2026 | 7 | 153 | 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 (101 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 unsuccessful knee replacement or other procedure.
- Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture-management techniques
The Triathlon® Gold Femoral Components are indicated for both uncemented and cemented use.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252044 · printed Nov 5, 2026
Cite this page
510(k) Report. “K252044: Triathlon® Total Knee System - Triathlon® Gold Femoral Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K252044
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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