# K073551: Smith & Nephew Instrument Trays

- Pathway: 510(k) (Abbreviated)
- Applicant: Smith & Nephew Inc., Endoscopy Div.
- Decided: May 21, 2008 after 155 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: 4 generations back to K844002 (1984). 7 ancestors in all.
13 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 1.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K090562: Smith & Nephew Instrument Trays (2009), 12 descendants of its own
- K102103: Skeletal Dynamics Sterilization Trays (2010), 4 descendants of its own
- K091627: Smith & Nephew Instrument Trays (2009), 4 descendants of its own
- K143579: NuVasive Sterilization Trays (2015), 3 descendants of its own
- K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray (2018), 2 descendants of its own

## Indications for use
The Smith & Nephew instrument tray is intended to contain Smith & Nephew reusable surgical instruments for convenient organized storage, sterilization and transport between usages. The instrument tray is suitable for use in prevacuum steam and high temperature gravity steam sterilization methods. The instrument tray is not intended to maintain sterility; it is intended to be used in conjunction with a validated sterilization wrap in order to maintain sterility of the enclosed devices. Validated Sterilization Parameters: Method: Prevacuum Steam; Temperature: 132 0C - 135 0C (270°F-275 0 F); Exposure Time: 4 minutes; Drying Time: 30 minutes. Method: High Temperature Gravity Steam; Temperature: 132 0C (270%); Exposure Time: 10 minutes; Drying Time: 70 minutes. Device model that is the subject of this pre-market notification: 72201731 Tray, ACUFEX° DIRECTOR ELITE ° Drill Guide Systems

Source page: https://510kreport.com/device/K073551
Methodology: https://510kreport.com/methodology