510(k) · Cleared
Recalled · Class II · 2021Triathlon Tritanium Metal-Backed Patella
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Orthopaedics · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Cleared on Nov 26, 2013 as substantially equivalent to K123486 (Stryker, 2013) and 4 other predicates after a 96-day review. Its family tree reaches back 5 generations to 1995. 38 later devices descend from it. It has been recalled once.
- Decided
- Nov 26, 2013
- Review
- 96 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 1
- Predicates
- 5
Its longest line of descent runs back 5 generations to K933785 (1995). 16 ancestors in all. 38 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK933785 Next Generation Knee SystemZimmer, Inc. · 1995 · Recalled
- 4 generations backK023211 Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral…Zimmer, Inc. · 2002 · Recalled
- 3 generations backK031061 Nexgen Porous, Uncemented Femoral and Tibial Baseplate ComponentsZimmer, Inc. · 2003 · Recalled
- 2 generations backK072160 Nexgen Trabecular Metal Tibial TrayZimmer, Inc. · 2007 · Recalled
- 1 generation backK123486 Triathlon Tritanium Tibial BaseplateStryker · 2013 · Recalled
- This deviceK132624 Triathlon Tritanium Metal-Backed PatellaStryker Orthopaedics · 2013
- 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 · cites it directly · 5 of its ownK211221 Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK230952 Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2023
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · 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
- K211221Porous Patella and Porous Tibia BaseplateSmith & Nephew, Inc. · 2021 · cites it directly5descendants
- K230952Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral ComponentHowmedica 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 |
|---|---|---|---|---|---|
| −5 | K933785 | Next Generation Knee System | Zimmer, Inc. | 1995 | 83 |
| −4 | K023211 | Nexgen Complete Knee Solution Cruciate Retaining (CR)-Flex Femoral Components | Zimmer, Inc. | 2002 | 6 |
| −3 | K031061 | Nexgen Porous, Uncemented Femoral and Tibial Baseplate Components | Zimmer, Inc. | 2003 | 24 |
| −2 | K072160 | Nexgen Trabecular Metal Tibial Tray | Zimmer, Inc. | 2007 | 1 |
| −1 | K123486 | Triathlon Tritanium Tibial Baseplate | Stryker | 2013 | 7 |
| 0 (this device) | K132624 | Triathlon Tritanium Metal-Backed Patella | Stryker Orthopaedics | 2013 | — |
| +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 | — |
| +1 | K211221 | Porous Patella and Porous Tibia Baseplate | Smith & Nephew, Inc. | 2021 | — |
| +2 | K230952 | Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS)… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2023 | — |
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 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 6 | 0 |
| 2021 | 2 | 0 |
| 2022 | 5 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 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? (5)
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 |
|---|---|---|---|
| * | K123486 | Triathlon Tritanium Tibial BaseplateSummary page 1…thesis (888.3560) Product Codes: MBH, .JWH Legally Marketed Devices to Which Substantial Equivalence isCtaimed: * Triathlon' Tritaniuml Tibial Baseplate (K123486) * Triathlon' Metal-Backed Patella (K061521) * Triathlon" X3 Patellar Components (cleared as part of the TriathlonO X3& UHM… | 2013 |
| * | K061521 | Triathlon Metal Backed PatellaSummary page 1…H, .JWH Legally Marketed Devices to Which Substantial Equivalence isCtaimed: * Triathlon' Tritaniuml Tibial Baseplate (K123486) * Triathlon' Metal-Backed Patella (K061521) * Triathlon" X3 Patellar Components (cleared as part of the TriathlonO X3& UHMWPE Tibial Inserts and Patellar Componen… | 2006 |
| * | K051146 | Triathlon Knee SystemSummary page 1…thlon' Metal-Backed Patella (K061521) * Triathlon" X3 Patellar Components (cleared as part of the TriathlonO X3& UHMWPE Tibial Inserts and Patellar Components, K051146) * Triathlon' Asymmetric and Symmetric Patellar Components (cleared as part of the TriathlanO CR Total Knee System, K04… | 2005 |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 1…al Inserts and Patellar Components, K051146) * Triathlon' Asymmetric and Symmetric Patellar Components (cleared as part of the TriathlanO CR Total Knee System, K040267) * Scorpio' X3 Recessed Patella (cleared as part of the Scorpioe X3 TM UHMWPE Tibial Inserts and ScorpioS X3 TM UHMWPE… | 2004 |
| * | K051977 | Scorpio Knee System Tibial Inserts and Patellar ComponentsSummary page 1…ee System, K040267) * Scorpio' X3 Recessed Patella (cleared as part of the Scorpioe X3 TM UHMWPE Tibial Inserts and ScorpioS X3 TM UHMWPE Patellar Components, K051977) Device Description: The TriathionO Tritaniurn' Metal-Backed Patella isan extension of the Triathlon" Total Knee System product… | 2005 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | 2017 | 24 |
| K211221 | Porous Patella and Porous Tibia Baseplate | 2021 | 5 |
| K202194 | ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized… | 2020 | 4 |
| K212941 | Porous Patella | 2022 | 1 |
| K252898 | Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patella… | 2025 | 0 |
| K243656 | U2 Total Knee System – PF+ Patella; USTAR II System– PF+ Patella | 2025 | 0 |
| K220049 | Optimotion Implants Porous Metal-Backed Patella | 2022 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 5, 2021 | Class II | Z-1379-2021 | Under Investigation by firm | The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 15 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.
- 8 other devices also cite its predicate K123486.
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: 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 (234 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' TritaniumO Tibial Baseplate and Tritaium' Metal-Backed Patella components are
indicated for both uncernented and cemented use.
The TriathionO Total Knee System beaded and beaded with Peri-Apatite components are
Intended for uncemented use only.
The TriathlonO All Polyethylene tiblal components are indicated far cemented use only.
Additional indications for Posterior Stabilized (PS) and Total Stabilizer (TS) Components:
"Lgamentous Instability requiring implant bearing surface geometries with increased
constraint.
' Absent or non-functioning posterior cruciate ligament.
* Severe anteroposterior Instability of the knee joint.
Additional Indications for Total Stabilizer (7S) Components:
* Severe instability of the knee secondary to compromised collateral ligament integrity or
function.
Indications for 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 sur gical procedure,
accompanied by bane loss.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132624 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132624: Triathlon Tritanium Metal-Backed Patella.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132624
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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