# K091806: Pogo Screw Instrumentation Tray

- Pathway: 510(k) (Traditional)
- Applicant: Fxdevices
- Decided: Feb 22, 2010 after 249 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: 5 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)
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) Summary page 1.

## Indications for use
The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set. The trays are not intended to maintain sterility by themselves. They are designed to, facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components. Sterilization Cycle Parameters Method: Steam or Method: Steam Cycle: Pre-vacuum Cycle: Gravity Temperature: 1320C Temperature: 1320C Exposure: 4 minutes Exposure: 15 minutes Drying Time: 30 minutes Drying Time: 80 minutes

Source page: https://510kreport.com/device/K091806
Methodology: https://510kreport.com/methodology