# K152969: Enhance Allograft Wedge Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Corporation
- Decided: Mar 31, 2016 after 175 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: 2 generations back to K080531 (2008). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090560: Conmed Linvatec Anodized Aluminum Sterilization Trays, Conmed Linvatec (2009) Summary page 4.

## Indications for use
The Enhance Allograft Wedge Instrumentation Tray (T903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments: REF Description REF Description 903106 Evans Trial 6mm 903206 Cotton Trial 6mm 903108 Evans Trial 8mm 903207 Cotton Trial 7mm 903110 Evans Trial 10mm 903208 Cotton Trial 8mm 903112 Evans Trial 12mm 903006 Mallet 903010 Tamp Evans 903008 Distractor 903012 Tamp Cotton 903002 Osteotome 16mm 903205 Cotton Trial 5mm 903004 Osteotome 10mm The Enhance Allograft Wedge Instrumentation Tray (T903) is not intended to maintain sterility; it is intended to be used in conjunction with a validated FDA cleared sterilization wrap in order to maintain sterility of the enclosed medical instruments. Sterilize the instrument tray using the following sterilization parameters: Method Cycle Temperature Exposure Dry Cycle Cool Down Duration Steam Pre-vacuum 270°F (132°C) 4 minutes 20 minutes 118°F (48°C) 25 minutes (wrapped) Steam Gravity 250°F (121°C) 30 minutes 15 minutes 118°F (48°C) 37 minutes (wrapped) - Validation was conducted using an FDA cleared sterilization wrap with a maximum load 14 lbs. (6.4 kg). - Only single unstacked trays may be used during the sterilization process. - Double wrap tray using an FDA cleared wrap.

Source page: https://510kreport.com/device/K152969
Methodology: https://510kreport.com/methodology