# K173391: OsteoMed QuickFix Hybrid MMF Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Osteomed, LLC
- Decided: May 10, 2018 after 192 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: 8 generations back to K844002 (1984). 11 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143579: NuVasive Sterilization Trays, Nu Vasive, Incorporated (2015) Summary page 4.

## Most influential descendants
- K212068: Biotech Dental Kits (2021), 0 descendants of its own
- K202105: OsteoMed ExtremiFix Mini & Small System Tray (2020), 0 descendants of its own

## Indications for use
The OsteoMed MMF Sterilization Tray is intended to contain MMF implants and surgical instruments for sterilization, storage and handling. The OsteoMed MMF Sterilization Tray is suitable for dynamic air removal (pre-vacuum) steam sterilization methods. The 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 sterilization tray may also be used in conjunction with a legally marketed rigid container. Sterilization validation was performed on MMF implants and accessories such as surgical instrumentation. Do not exceed a maximum load of 2.3 Ibs. in the sterilization tray. Validated sterilization parameters for OsteoMed MMF Sterilization Tray: 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/K173391
Methodology: https://510kreport.com/methodology