510(k) · Cleared
Recalled · Class II · 2024Triathlon Total Knee System
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 Feb 2, 2018 as substantially equivalent to K172634 (Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, 2017) and 7 other predicates after a 45-day review. Its family tree reaches back 10 generations to 1994. 14 later devices descend from it. It has been recalled 3 times.
- Decided
- Feb 2, 2018
- Review
- 45 days
- Class
- Class II
- Product code
- MBH
- Recalls
- 3
- Predicates
- 8
Its longest line of descent runs back 10 generations to K943462 (1994). 85 ancestors in all, the oldest K880155 (1988). 14 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 6 generations between
- 3 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 2 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 1 generation backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- This deviceK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018
- 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 · 3 generations on · 3 of its ownK242831 Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024
- Descendant · 2 generations on · 3 of its ownK201343 Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020
- Descendant · cites it directly · 2 of its ownK200395 LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020
Show all 10 generations
- Root · 10 generations backK943462 Darwin Knee SystemJohnson & Johnson Professionals, Inc. · 1994 · Recalled
- 9 generations backK033272 Depuy Sigma Tibial InsertsDePuy Orthopaedics, Inc. · 2004 · Recalled
- 8 generations backK040166 Depuy Sigma XLK Tibial InsertsDePuy Orthopaedics, Inc. · 2004
- 7 generations backK061648 Depuy Graduated Compartmental Knee (GCK)DePuy Orthopaedics, Inc. · 2006 · Recalled
- 6 generations backK070849 Depuy GCK Femoral and Tibial ComponentsDePuy Orthopaedics, Inc. · 2007
- 5 generations backK082172 Mako Modular Knee Compartmental Implant SystemMako Surgical Corporation · 2008 · Recalled
- 4 generations backK090763 Restoris Multicompartmental Knee (MCK) SystemMako Surgical Corporation · 2009 · Recalled
- 3 generations backK133039 Restoris Multicompartmental Knee SystemMako Surgical Corporation · 2013
- 2 generations backK150307 RESTORIS Multicompartmental Knee SystemMako Surgical Corp. · 2015
- 1 generation backK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- This deviceK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- 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
- K242831Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components; Triathlon…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024 · 3 generations on3descendants
- K201343Triathlon Total KneeSystemHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2020 · 2 generations on3descendants
- K200395LOSPA II Knee System (EXULT Knee Replacement System)Corentec Co., Ltd. · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943462 | Darwin Knee System | Johnson & Johnson Professionals, Inc. | 1994 | 8 |
| −9 | K033272 | Depuy Sigma Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | 51 |
| −8 | K040166 | Depuy Sigma XLK Tibial Inserts | DePuy Orthopaedics, Inc. | 2004 | — |
| −7 | K061648 | Depuy Graduated Compartmental Knee (GCK) | DePuy Orthopaedics, Inc. | 2006 | 1 |
| −6 | K070849 | Depuy GCK Femoral and Tibial Components | DePuy Orthopaedics, Inc. | 2007 | — |
| −5 | K082172 | Mako Modular Knee Compartmental Implant System | Mako Surgical Corporation | 2008 | 2 |
| −4 | K090763 | Restoris Multicompartmental Knee (MCK) System | Mako Surgical Corporation | 2009 | 5 |
| −3 | K133039 | Restoris Multicompartmental Knee System | Mako Surgical Corporation | 2013 | — |
| −2 | K150307 | RESTORIS Multicompartmental Knee System | Mako Surgical Corp. | 2015 | — |
| −1 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| 0 (this device) | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | — |
| +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 | — |
| +3 | K242831 | Triathlon Knee System; Triathlon Pro Posterior Stabilized Femoral Components… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2024 | — |
| +2 | K201343 | Triathlon Total KneeSystem | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2020 | — |
| +1 | K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | Corentec Co., Ltd. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 6 | 0 |
| 2008 | 3 | 0 |
| 2010 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 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? (8)
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 |
|---|---|---|---|
| * | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsSummary page 5…) Product Codes: MBH, JWH Legally Marketed Device to Which Substantial Equivalence is Claimed: • Triathlon X3 ETO Tibial Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K03… | 2017 |
| * | K040267 | Triathlon Cruciate Retaining (CR) Total KneeSummary page 5…keted Device to Which Substantial Equivalence is Claimed: • Triathlon X3 ETO Tibial Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS… | 2004 |
| * | K042883 | Size 1 Triathlon Cruciate Retaining (CR) Tibial InsertSummary page 5…ice to Which Substantial Equivalence is Claimed: • Triathlon X3 ETO Tibial Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS Total Kn… | 2004 |
| * | K051380 | Triathlon Press-Fit Total Knee SystemSummary page 5…ich Substantial Equivalence is Claimed: • Triathlon X3 ETO Tibial Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS Total Knee System… | 2005 |
| * | K141056 | Triathlon Knee System Posterior Stabilized ComponentsSummary page 5…antial Equivalence is Claimed: • Triathlon X3 ETO Tibial Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS Total Knee System X3 and N… | 2014 |
| * | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemSummary page 5…uivalence is Claimed: • Triathlon X3 ETO Tibial Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS Total Knee System X3 and N2Vac Tibi… | 2017 |
| * | K031729 | Triathlon Posteriorly Stabilized (PS) Total Knee SystemSummary page 5…l Inserts and Patellar Components – K172634 • Triathlon CR N2Vac Tibial Inserts – K040267, K042883, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS Total Knee System X3 and N2Vac Tibial Inserts – K063423, K141056, K172326 De… | 2003 |
| * | K063423 | Triathlon CS (Condylar Stabilizing) Lipped InsertSummary page 5…, K051380, K141056, K172326 • Triathlon PS N2Vac Tibial Inserts – K031729, K051380, K141056, K172326 • Triathlon CS Total Knee System X3 and N2Vac Tibial Inserts – K063423, K141056, K172326 Device Description: The subject Triathlon Intermediate Tibial Inserts will be available in the followin… | 2007 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190402 | Triathlon Total Knee System-Additional Components | 2019 | 11 |
| K200395 | LOSPA II Knee System (EXULT Knee Replacement System) | 2020 | 2 |
| K240669 | ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System | 2024 | 1 |
| K261898 | Triathlon® Knee System; Triathlon® Hinge Knee System; Scorpio® Total Knee System | 2026 | 0 |
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-1259-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Feb 6, 2024 | Class II | Z-1260-2024 | Packaging | Potential packaging breaches of inner blister and outer sterile blister. |
| Apr 13, 2023 | Class II | Z-1653-2023 | 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 |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 47 of the 85 ancestors have a recall of any class.
- Of its descendants, K190402 (Stryker Orthopaedics (Aka Howmedica Osteonics Corp.), 2019) has gone furthest, with 11 descendants of its own.
- 3 other devices also cite its predicate K172634.
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. 2018, 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 (272 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® 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:
• Ligamentous 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 (TS) 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 surgical procedure, accompanied by bone loss.
Additional Indications for Cone Augments:
• Severe degeneration or trauma requiring extensive resection and replacement
• Femoral and Tibial bone voids
• 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/K173849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173849: Triathlon Total Knee System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173849
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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