# K170226: iTotal Family Reusable Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Conformis, Inc.
- Decided: Oct 25, 2017 after 273 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K844002 (1984). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161347: Signia sterilization tray, Covidien (2016) Summary page 5.
- K130532: Idrive Ultra Sterilization Tray, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 5.

## Indications for use
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

Source page: https://510kreport.com/device/K170226
Methodology: https://510kreport.com/methodology