# K100887: Versitomic Acl Flexible Reamer System Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Tag Medical Products
- Decided: Aug 9, 2010 after 132 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). 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)
- K032119: Paragon Medical Surgical Instrument Delivery System Various, Paragon Medical, Inc. (2003) Summary page 1.

## Indications for use
The VersiTomicTm ACL Flexible Reamer System Sterilization Tray is indicated to enclose the VersiTomnic ACL Flexible Reamer System instruments that are to be sterilized by a health care provider. The Sterilization Tray consists of an interlocking tray and lid, which are both perforated to allow the passage of the sterilizing agent from outside the tray to the devices placed inside. The VersiTomicTm ACL Flexible Reamer System Sterilization tray has been validated with a load that consists of various metallic instruments and implants up to a length of 340 mm and minimum internal diameter of 1.4 mm. The maximum load is 9.6 kg (21.1 lb) which is distributed equally within the tray. The VersiTomiCTm ACL Flexible Reamer System Sterilization Tray has been validated for steam sterilization using the following parameters: Gravity-Displacement Steam Sterilization * Sterilizer Type: Gravity * Minimum Temperature: 1320C (2700 F) * Minimum Exposure Time: 10 minutes * Minimum Dry Time: 40 minutes Pre-Vacuum Steam Sterilization *Sterilizer Type: Pre-Vacuum * Minimum Temperature: 13200 (2700 F) * Minimum Exposure Time: 4 minutes * Minimum Dry Time: 15 minutes

Source page: https://510kreport.com/device/K100887
Methodology: https://510kreport.com/methodology