510(k) · Cleared
Recalled · Class II · 2026Triathlon Tritanium Tibial Baseplate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on May 3, 2013 as substantially equivalent to K051380 (Howmedica Osteonics Corp., 2005) and 1 other predicate after a 171-day review. Its family tree reaches back 4 generations to 1995. 51 later devices descend from it. It has been recalled 7 times.
- Decided
- May 3, 2013
- Review
- 171 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 7
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933785 (1995). 12 ancestors in all. 51 later devices descend from it, 9 citing it directly.
- Root · 4 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 3 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 2 generations backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- 1 generation backK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- This deviceK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013
- Descendant · cites it directly · 38 of its ownK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · Recalled
- Descendant · cites it directly · 28 of its ownK141056 Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · Recalled
- 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 · cites it directly · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K132624Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013 · cites it directly38descendants
- K141056Triathlon Knee System Posterior Stabilized ComponentsStryker Orthopaedics · 2014 · cites it directly28descendants
- 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 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −3 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −2 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| −1 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| 0 (this device) | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | — |
| +1 | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | 1 |
| +1 | K141056 | Triathlon Knee System Posterior Stabilized Components | Stryker Orthopaedics | 2014 | 11 |
| +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 |
| +1 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 8 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 7 | 0 |
| 2026 | 7 | 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 1…cemented prosthesis (888.3560, 87JWH) Legally Marketed Device to Which Substantial Equivalence is Claimed: *Howmedica Osteonics Corp. - Triathion® Total Knee System - K05 1380 *Zimmer, Inc. - Nex~en® Trabecular MetalTM Tibiai Tray - K072160 Device Description: The Triathion® Tritanium Tibial Baseplate… | 2005 |
| * | K072160 | Nexgen Trabecular Metal Tibial TraySummary page 1…Which Substantial Equivalence is Claimed: *Howmedica Osteonics Corp. - Triathion® Total Knee System - K05 1380 *Zimmer, Inc. - Nex~en® Trabecular MetalTM Tibiai Tray - K072160 Device Description: The Triathion® Tritanium Tibial Baseplate is an extension of the Triathlon® Total Knee System product line f… | 2007 |
What descends from it? (51)
See all 519 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132624 | Triathlon Tritanium Metal-Backed Patella | 2013 | 38 |
| K141056 | Triathlon Knee System Posterior Stabilized Components | 2014 | 28 |
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 | 24 |
| K190402 | Triathlon Total Knee System-Additional Components | 2019 | 11 |
| K182346 | TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws | 2018 | 5 |
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized… | 2020 | 4 |
| K221850 | GMK 3D Metal Tibial Tray | 2022 | 1 |
| K191084 | The Optimotion Blue Total Knee System | 2020 | 1 |
| K162256 | Klassic Femur, Porous, Klassic Tibial Baseplate, Porous | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 19, 2026 | Class II | Z-2462-2026 | Under Investigation by firm | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in… |
| May 19, 2026 | Class II | Z-2461-2026 | Under Investigation by firm | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in… |
| Mar 30, 2022 | Class II | Z-1237-2022 | Under Investigation by firm | Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling. |
| Feb 10, 2021 | Class II | Z-1186-2021 | Under Investigation by firm | Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the… |
| Jun 23, 2016 | Class II | Z-2390-2016 | Process control | It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was… |
| Sep 29, 2015 | Class II | Z-0249-2016 | Nonconforming Material/Component | Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use. |
| Feb 12, 2015 | Class II | Z-1283-2015 | Device Design | Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly. |
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 18 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 12 of the 12 ancestors have a recall of any class.
- Of its descendants, K132624 (Stryker Orthopaedics, 2013) has gone furthest, with 38 descendants of its own.
- 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. 2013, 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: non-inflammatory 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 (135 words)
General Total Knee Arthroplasty (TKR) Indications:
- Painful, disabling joint disease of the knee resulting from: non-inflammatory 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
Additional Indications for Posterior Stabilizing (PS) 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
The Triathlon® Tritanium® Tibial Baseplates are indicated for both cemented and uncemented use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123486 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123486: Triathlon Tritanium Tibial Baseplate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123486
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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