510(k) · Cleared
ClearedEZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
K1 Medical, LLC · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Dec 2, 2020 as substantially equivalent to K192487 (K1 Medical, LLC, 2019) after a 113-day review. Its family tree reaches back 8 generations to 1984. 2 later devices descend from it.
- Decided
- Dec 2, 2020
- Review
- 113 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844002 (1984). 14 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 7 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 6 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 5 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 4 generations backK040223 Polyvac Instrument Delivery SystemSymmetry Medical USA, Inc. · 2004
- 3 generations backK120947 THS Instrument TrayHologic, Inc. · 2012
- 2 generations backK152241 Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc. · 2016
- 1 generation backK192487 EZ-TRAX Containment DeviceK1 Medical, LLC · 2019
- This deviceK202270 EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC · 2020
- Descendant · cites it directly · 1 of its ownK211007 EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK213209 EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System…K1 Medical, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −7 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −6 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −5 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −4 | K040223 | Polyvac Instrument Delivery System | Symmetry Medical USA, Inc. | 2004 | — |
| −3 | K120947 | THS Instrument Tray | Hologic, Inc. | 2012 | — |
| −2 | K152241 | Medtronic Transportation/Sterilization Cassettes | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| −1 | K192487 | EZ-TRAX Containment Device | K1 Medical, LLC | 2019 | — |
| 0 (this device) | K202270 | EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device | K1 Medical, LLC | 2020 | — |
| +1 | K211007 | EZ-TRAXTM Persona Knee Containment Device | K1 Medical, LLC | 2021 | — |
| +2 | K213209 | EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment… | K1 Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 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 KCT? 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 KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K192487 | EZ-TRAX Containment DeviceSummary page 4…sette Classification Name: Sterilization Wrap Regulatory Class: Class II, 21 CFR 880.6850 Product Code: KCT Predicate Device: EZ-TRAXTM Containment Device, K1 Medical, K192487 Device Description The EZ-TRAXTM Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory i… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211007 | EZ-TRAXTM Persona Knee Containment Device | 2021 | 1 |
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 36 years and passes through 8 companies; a new generation was cleared every 3.3 years on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K211007 (K1 Medical, LLC, 2021) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, 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 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated…
Read the full statement (232 words)
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is intended for use as an accessory in healthcare facilities to organize, enclose, reprocess, transport, and store Stryker Mako Total Knee with Triathlon devices between surgical uses. The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is not intended on its own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterile barrier system.
Cycle: Dynamic Air Removal
Temperature: 270 F/132 C
Exposure Time: 4 minutes
Drying Time: 10 minutes
Sterilization validations included the worst case load configurations of the EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device utilized the Stryker Mako Total Knee with Triathlon Devices required to perform an arthroplasty procedure.
Contents in the validated configuration include: reusable surgical instruments (impactors, trials, , MICS, sagital saws,.arrays, etc.)
No lumened devices were validated within the tray system as part of the product load. The EZ- TRAX™ Stryker Mako Total Knee with Triathlon Containment Device does not have any lumen claims
Healthcare facilities should not exceed 25 pounds (EZ- TRAX™ Containment Device + sterile barrier system + Stryker Mako Total Knee with Triathlon Containment devices).
The EZ-TRAX™ Stryker Mako Total Knee with Triathlon Containment Device is offered in the following sizes:
Brand Name Model Dimensions
EZ-TRAX™ BASE.ASSY.AL.24.12.2.4 L) 22.97” (W) 11.18” (H) 2.44”
EZ-TRAX™ BASE.ASSY.AL.21.12.4 (L) 19.97” (W) 11.18” (H) 4.187”
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202270 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202270: EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202270
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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