510(k) · Cleared
ClearediTotal Family Reusable Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conformis, Inc. · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Oct 25, 2017 as substantially equivalent to K161347 (Covidien, 2016) and 1 other predicate after a 273-day review. Its family tree reaches back 6 generations to 1984.
- Decided
- Oct 25, 2017
- Review
- 273 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K844002 (1984). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK844002 HU-Friedy Ims Cassette SystemHu-Friedy Mfg. Co., Inc. · 1984
- 5 generations backK980065 C/T Med-Systems Cassette SystemC/T Med System, Ltd. · 1998
- 4 generations backK990761 Tuttnauer Mini Container Cassette, Tuttnauer Standard Case CassetteTuttnauer U.S.A Co, Ltd. · 1999
- 3 generations backK012105 Polyvac Surgical Instrument Delivery SystemSymmetry Medical, Inc. · 2002
- 2 generations backK130532 Idrive Ultra Sterilization TrayCovidien, Formerly US Surgical A Divison of Tyco H · 2013
- 1 generation backK161347 Signia sterilization trayCovidien · 2016
- This deviceK170226 iTotal Family Reusable Instrument TrayConformis, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844002 | HU-Friedy Ims Cassette System | Hu-Friedy Mfg. Co., Inc. | 1984 | — |
| −5 | K980065 | C/T Med-Systems Cassette System | C/T Med System, Ltd. | 1998 | — |
| −4 | K990761 | Tuttnauer Mini Container Cassette, Tuttnauer Standard Case Cassette | Tuttnauer U.S.A Co, Ltd. | 1999 | — |
| −3 | K012105 | Polyvac Surgical Instrument Delivery System | Symmetry Medical, Inc. | 2002 | — |
| −2 | K130532 | Idrive Ultra Sterilization Tray | Covidien, Formerly US Surgical A Divison of Tyco H | 2013 | — |
| −1 | K161347 | Signia sterilization tray | Covidien | 2016 | — |
| 0 (this device) | K170226 | iTotal Family Reusable Instrument Tray | Conformis, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 2001 | 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 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? (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 |
|---|---|---|---|
| * | K161347 | Signia sterilization traySummary page 5…II Devices (Predicate Product Code: KCT Devices): Regulation Number: 21 CFR 888.6850 510(k) Number: K161347 iDrive™ Ultra Sterilization Tray Device Class: II… | 2016 |
| * | K130532 | Idrive Ultra Sterilization TraySummary page 5…II Product Code: KCT Regulation Number: 21 CFR 880.6850 510(k) Number: K130532 Page 2 of 7 510(K) SUMMARY (K170226) Device Description: The iTotal Family Reusable Instrument Tray is… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 7 companies; a new generation was cleared every 3.3 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K161347.
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. 2017, 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 iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization and configuration during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices…
Read the full statement (119 words)
The iTotal Family Reusable Instrument Tray is intended to house the reusable instrumentation associated with ConforMIS knee implant systems and define their organization and configuration during sterilization, transportation, and storage within the hospital environment. The iTotal Family Reusable Instrument Tray can hold up to 17lbs of instruments. The iTotal Family Reusable Instrument Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration.
The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows:
Cycle Type: Pre-vacuum
Temperature: 132°C (270°F)
Exposure Time: 4 minutes
Dry Time: 30 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170226 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170226: iTotal Family Reusable Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170226
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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