# K143579: NuVasive Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: Nu Vasive, Incorporated
- Decided: Aug 28, 2015 after 253 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: 7 generations back to K844002 (1984). 10 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102103: Skeletal Dynamics Sterilization Trays, Skeletal Dynamics, LLC (2010) Summary page 7.

## Most influential descendants
- K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray (2018), 2 descendants of its own
- K212068: Biotech Dental Kits (2021), 0 descendants of its own
- K202105: OsteoMed ExtremiFix Mini & Small System Tray (2020), 0 descendants of its own

## Indications for use
The NuVasive Sterilization Trays are intended to contain NuVasive implants and surgical instruments for sterilization, storage and handling. The NuVasive Sterilization Trays are suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The 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 devices. Sterilization validations for three level worst case tray (20.5" x 10" x 7.375") included three different loading configurations: implant only content (26.4 Ibs.), instrument only content (39.95 1bs.) and mixed instruments and implants content (30.45 lbs.) Validated worst case loading configurations included 23 instruments with lumens including the following worst case lumen dimensions: - 1.6 mm x 306.8 mm - 1.1 mmx 166.4 mm -7.2mmx 331.9 mm -5.5mmx 356.9 mm Do not exceed a maximum load of 25 1bs in the sterilization tray. Validated sterilization parameters for NuVasive Sterilization Trays: Method: Steam Cycle: Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes Minimum Cool Down Time: 40 minutes

Source page: https://510kreport.com/device/K143579
Methodology: https://510kreport.com/methodology