# K202105: OsteoMed ExtremiFix Mini & Small System Tray

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed, LLC
- Decided: Oct 29, 2020 after 92 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: 9 generations back to K844002 (1984). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray, Osteomed, LLC (2018) Summary page 4.

## Indications for use
The OsteoMed Mini & Small System Tray is intended to contain Mini and Small implants and surgical instruments for sterilization, storage and handling. The OsteoMed Mini & Small System Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The system tray 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 devices. The System Tray may also be used in conjunction with a legally marketed rigid container. Sterilization validation was performed utilizing the ExtremiFix Mini & Small Cannulated Screw System implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 14.1 lbs. in the sterilization system tray. Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a wrapped configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 50 minutes Validated sterilization parameters for OsteoMed ExtremiFix Mini & Small System Tray in a rigid container configuration: Method: Steam Cycle Pre-Vacuum Temperature: 270°F (132°C) Exposure Time: 4 minutes Minimum Dry Time: 30 minutes

Source page: https://510kreport.com/device/K202105
Methodology: https://510kreport.com/methodology