510(k) · Cleared
ClearedTriathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts
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 · HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Cleared on Jun 7, 2018 as substantially equivalent to K071881 (Howmedica Osteonics Corp., 2007) and 2 other predicates after a 91-day review. Its family tree reaches back 10 generations to 1994. 3 later devices descend from it.
- Decided
- Jun 7, 2018
- Review
- 91 days
- Class
- Class II
- Product code
- HSX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K943462 (1994). 84 ancestors in all, the oldest K880155 (1988). 3 later devices descend from it, 2 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 deviceK180612 Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2018
- Descendant · cites it directly · 1 of its ownK203099 Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2020
- Descendant · 2 generations on · 0 of its ownK241260 ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK220930 Restoris Multi-Compartmental Knee SystemMako Surgical Corp. · 2022
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 deviceK180612 Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial InsertsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2018
Most influential descendants
Showing 3 of 3 · See all- K203099Triathlon PKR SystemHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics · 2020 · cites it directly1descendant
- K241260ACTIFY™ Unicondylar Knee SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
- K220930Restoris Multi-Compartmental Knee SystemMako Surgical Corp. · 2022 · cites it directly0descendants
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) | K180612 | Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2018 | — |
| +1 | K203099 | Triathlon PKR System | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics | 2020 | — |
| +2 | K241260 | ACTIFY™ Unicondylar Knee System | Globus Medical, Inc. | 2024 | — |
| +1 | K220930 | Restoris Multi-Compartmental Knee System | Mako Surgical Corp. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 HSX? 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 HSX device
- #1 K261609 Freedom Partial Knee Systemscore 15.1 · 12 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 |
|---|---|---|---|
| * | K071881 | Triathlon PKR SystemSummary page 5…osthesis Product Codes: HSX, HRY, NPJ Legally Marketed Devices to Which Substantial Equivalence is Claimed: Triathlon PKR System X3 Tibial Inserts (K071881, K172326) Restoris Multicompartmental Knee (MCK) System X3 Tibial Inserts (K150307, K172326)… | 2007 |
| * | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemSummary page 5…Product Codes: HSX, HRY, NPJ Legally Marketed Devices to Which Substantial Equivalence is Claimed: Triathlon PKR System X3 Tibial Inserts (K071881, K172326) Restoris Multicompartmental Knee (MCK) System X3 Tibial Inserts (K150307, K172326)… | 2017 |
| * | K150307 | RESTORIS Multicompartmental Knee SystemSummary page 5…tantial Equivalence is Claimed: Triathlon PKR System X3 Tibial Inserts (K071881, K172326) Restoris Multicompartmental Knee (MCK) System X3 Tibial Inserts (K150307, K172326) K180612 - Page 2 o… | 2015 |
| † | K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components | 2017 |
What descends from it? (3)
2 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)
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 24 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 46 of the 84 ancestors have a recall of any class.
- Of its descendants, K203099 (Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K071881.
How does its category compare?
All HSX devicesHSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, 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 · HSX
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HSX
59in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HSX
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HSX
175in 2025
MAUDE reports naming product code HSX, 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 | 6 | 33 | 0 | 6 |
| 2008 | 4 | 102 | 0 | 4 |
| 2009 | 2 | — | 49 | 21 |
| 2010 | 3 | 74 | 0 | 58 |
| 2011 | 1 | — | 0 | 114 |
| 2012 | 5 | 88 | 0 | 83 |
| 2013 | 2 | — | 1 | 79 |
| 2014 | 0 | — | 0 | 66 |
| 2015 | 1 | — | 0 | 57 |
| 2016 | 3 | 147 | 1 | 107 |
| 2017 | 5 | 160 | 4 | 113 |
| 2018 | 2 | — | 0 | 159 |
| 2019 | 7 | 90 | 0 | 177 |
| 2020 | 4 | 40 | 2 | 273 |
| 2021 | 7 | 81 | 0 | 240 |
| 2022 | 2 | — | 0 | 257 |
| 2023 | 1 | — | 0 | 231 |
| 2024 | 4 | 133 | 0 | 172 |
| 2025 | 4 | 59 | 0 | 175 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Mako X3® Uni Onlay Tibial Inserts are components of the RESTORIS Multicompartmental Knee (MCK) System that is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include: * Medial unicondylar * Lateral…
Read the full statement (183 words)
Mako X3® Uni Onlay Tibial Inserts are components of the RESTORIS Multicompartmental Knee (MCK) System that is indicated for single or multi-compartmental knee replacement used in conjunction with RIO®, the Robotic Arm Interactive Orthopedic System, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces. The specific knee replacement configurations include:
* Medial unicondylar
* Lateral unicondylar
* Patellofemoral
* Medial bi-compartmental (medial unicondylar and patellofemoral)
RESTORIS Multicompartmental Knee (MCK) System is for single use only and is intended for implantation with bone cement.
Triathlon® PKR X3® Tibial Inserts are components of the Triathlon® PKR System that is indicated for:
* Moderately disabling joint disease of the knee resulting from painful osteo- or post traumatic arthritis
* Revision of previous unsuccessful surgical procedures, either involving, or not involving, previous use of a unicompartmental knee prosthesis
* As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis
* Where bone stock is of poor quality or inadequate for other reconstructive techniques as indicated by deficiencies of the femoral condyle/tibial plateau.
These components are intended for implantation with bone cement.
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/K180612 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180612: Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180612
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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