# K170939: Supplemental Instrument Trays

- Pathway: 510(k) (Traditional)
- Applicant: Nuvasive Specialized Orthopedics, Incorporated
- Decided: Aug 8, 2017 after 131 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151594: Ellipse Supplemental Instrument Trays, Ellipse Technologies, Incorporated (2016) Summary page 4.

## Indications for use
The N S O Supplemental Instrument Trays are intended to organize, protect, and transport instruments during steam sterilization and subsequent storage. NSO Supplemental Instrument Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. The following sterilization cycle is to be used: Pre-vacuum Steam Sterilization parameters: 132°C for 4 minutes with 40 minutes dry time The validated worst case loading configuration (non-stacked) for the Supplemental Instrument Trays included the following worst case lumen dimension and maximum weight for each of the trays:

Source page: https://510kreport.com/device/K170939
Methodology: https://510kreport.com/methodology