510(k) · Cleared
Recalled · Class II · 2024Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Nov 16, 2017 as substantially equivalent to K051146 (Howmedica Osteonics Corp., 2005) and 2 other predicates after a 76-day review. Its family tree reaches back 4 generations to 2003. 18 later devices descend from it. It has been recalled 7 times.
- Decided
- Nov 16, 2017
- Review
- 76 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 4 generations to K031729 (2003). 14 ancestors in all, the oldest K973164 (1997). 18 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK031729 Triathlon Posteriorly Stabilized (PS) Total Knee SystemHowmedica Osteonics Corp. · 2003 · Recalled
- 3 generations backK042993 Triathlon Posteriorly Stabilized (PS) Femoral ComponentHowmedica Osteonics Corp. · 2005 · Recalled
- 2 generations backK070095 Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007 · Recalled
- 1 generation backK072221 Modification to Triathlon TS Knee SystemHowmedica Osteonics Corp. · 2007
- This deviceK172634 Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2017
- Descendant · cites it directly · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- Descendant · cites it directly · 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 · cites it directly · 4 of its ownK223528 Triathlon® Hinge Knee SystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023 · Recalled
- Descendant · 3 generations on · 3 of its ownK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · cites it directly14descendants
- K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · cites it directly11descendants
- 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 · cites it directly4descendants
- K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee System | Howmedica Osteonics Corp. | 2003 | 3 |
| −3 | K042993 | Triathlon Posteriorly Stabilized (PS) Femoral Component | Howmedica Osteonics Corp. | 2005 | 1 |
| −2 | K070095 | Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | 13 |
| −1 | K072221 | Modification to Triathlon TS Knee System | Howmedica Osteonics Corp. | 2007 | — |
| 0 (this device) | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2017 | — |
| +1 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| +1 | 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 | — |
| +1 | K223528 | Triathlon® Hinge Knee System | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | 1 |
| +3 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 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 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? (3)
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 |
|---|---|---|---|
| * | K051146 | Triathlon Knee SystemSummary page 5…(888.3560) Product Codes: MBH, JWH Legally Marketed Devices to Which Substantial Equivalence is Claimed: x Triathlon® PS and CR X3® UHMWPE Tibial Inserts (K051146) x Triathlon® Symmetric and Asymmetric X3® UHMWPE Patellar Components (K051146) x Triathlon® CS X3® UHMWPE Tibial Inserts (… | 2005 |
| * | K063423 | Triathlon CS (Condylar Stabilizing) Lipped InsertSummary page 5…nd CR X3® UHMWPE Tibial Inserts (K051146) x Triathlon® Symmetric and Asymmetric X3® UHMWPE Patellar Components (K051146) x Triathlon® CS X3® UHMWPE Tibial Inserts (K063423) x Triathlon® TS X3® UHMWPE Tibial Inserts (K072221) Legally Marketed Reference Devices Used to Support Substantial Equivalen… | 2007 |
| * | K072221 | Modification to Triathlon TS Knee SystemSummary page 5…n® Symmetric and Asymmetric X3® UHMWPE Patellar Components (K051146) x Triathlon® CS X3® UHMWPE Tibial Inserts (K063423) x Triathlon® TS X3® UHMWPE Tibial Inserts (K072221) Legally Marketed Reference Devices Used to Support Substantial Equivalence: x Triathlon® PS Tibial Inserts (K031729) x Tr… | 2007 |
| † | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee System | 2003 |
| † | K040267 | Triathlon Cruciate Retaining (CR) Total Knee | 2004 |
| † | K042883 | Size 1 Triathlon Cruciate Retaining (CR) Tibial Insert | 2004 |
What descends from it? (18)
See all 184 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 |
|---|---|---|---|---|
| Feb 6, 2024 | Class II | Z-1261-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Class II | Z-1262-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Class II | Z-1265-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Class II | Z-1263-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Class II | Z-1264-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Class II | Z-1266-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Apr 13, 2023 | Class II | Z-1654-2023 | Under Investigation by firm | Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa |
The 5 latest of 7 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 14 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- 8 of the 14 ancestors have a recall of any class.
- Of its descendants, K173849 (Stryker Orthopaedics, 2018) has gone furthest, with 14 descendants of its own.
- 5 other devices also cite its predicate K051146.
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. 2017, 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: x 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. x Post-traumatic loss of knee joint configuration and function. x Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate…
Read the full statement (271 words)
General Total Knee Arthroplasty (TKR) Indications:
x 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.
x Post-traumatic loss of knee joint configuration and function.
x Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be
returned to adequate function and stability.
x Revision of previous unsuccessful knee replacement or other procedure.
x Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard
fracture-management techniques.
The Triathlon® Tritanium® Total Knee System components are indicated for both uncemented
and cemented use.
The Triathlon® Total Knee System beaded and beaded with Peri-Apatite components are
intended for uncemented use only.
The Triathlon® All Polyethylene tibial components are indicated for cemented use only.
Additional Indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
x Ligamentous instability requiring implant bearing surface geometries with increased
constraint.
x Absent or non-functioning posterior cruciate ligament.
x Severe anteroposterior instability of the knee joint.
Additional Indications for Total Stabilizer (TS) Components:
x Severe instability of the knee secondary to compromised collateral ligament integrity or
function.
Indications for Bone Augments:
x Painful, disabling joint disease of the knee secondary to: degenerative arthritis, rheumatoid
arthritis, or post-traumatic arthritis, complicated by the presence of bone loss.
x Salvage of previous unsuccessful total knee replacement or other surgical procedure,
accompanied by bone loss.
Additional Indications for Cone Augments:
x Severe degeneration or trauma requiring extensive resection and replacement
x Femoral and Tibial bone voids
x Metaphyseal reconstruction
The Triathlon TS Cone Augment components are intended for cemented or cementless use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172634: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172634
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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