# K080531: Conmed Linvatec Microfracture Instrument Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Conmed Linvatec
- Decided: Sep 5, 2008 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K003216: Paragon Medical Surgical Instrument Delivery Tray. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree

## Most influential descendants
- K090560: Conmed Linvatec Anodized Aluminum Sterilization Trays (2009), 1 descendant of its own
- K152969: Enhance Allograft Wedge Instrument Tray (2016), 0 descendants of its own

## Indications for use
The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is a containment device for medical device sterilization. The tray is constructed of metal and plastic with perforations to facilitate steam penetration. Method: Steam (wrapped); Cycle: Pre-vacuum; Minimum Temperature: 270°F (132°C); Minimum Exposure: 4 minutes; Minimum Dry Cycle: 8 minutes Method: Steam (wrapped); Cycle: Gravity; Minimum Temperature: 270°F (1320C); Minimum Exposure: 10 minutes; Minimum Dry Cycle: 8 minutes NOTES: 1. Sterilization validation has been conducted in accordance with the requirements of AAMI TIR 12. 2. Validation was conducted using an FDA cleared sterilization wrap with a maximum load of 8.1 lbs. (3.67 kg). The ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY) is intended for use with the following instruments: REF — Description MFX-OLT — Microfracture Awl, 0 degrees light MFX-30LT — Microfracture Awl, 30 degree light MFX-45LT — Microfracture Awl, 45 degrees light MFX-90LT — Microfracture Awl, 90 degrees light MFX-0HV — Microfracture Awl, 0 degrees heavy MFX-30HV — Microfracture Awl, 30 degrees heavy MFX-45HV — Microfracture Awl, 45 degrees heavy MFX-90HV — Microfracture Awl, 90 degrees heavy MFX-30ANG — Microfracture Awl, Angled, 30 Degrees Heavy MFX-45CU — Microfracture Awl Currette, 45 Degrees

Source page: https://510kreport.com/device/K080531
Methodology: https://510kreport.com/methodology