510(k) · Cleared
ClearedConmed Linvatec Microfracture Instrument Sterilization Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Sep 5, 2008 after a 192-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 2 later devices descend from it.
- Decided
- Sep 5, 2008
- Review
- 192 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
2 later devices descend from it, 1 citing it directly.
- This deviceK080531 Conmed Linvatec Microfracture Instrument Sterilization TrayConmed Linvatec · 2008
- Descendant · cites it directly · 1 of its ownK090560 Conmed Linvatec Anodized Aluminum Sterilization TraysConmed Linvatec · 2009
- Descendant · 2 generations on · 0 of its ownK152969 Enhance Allograft Wedge Instrument TrayConmed Corporation · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080531 | Conmed Linvatec Microfracture Instrument Sterilization Tray | Conmed Linvatec | 2008 | — |
| +1 | K090560 | Conmed Linvatec Anodized Aluminum Sterilization Trays | Conmed Linvatec | 2009 | — |
| +2 | K152969 | Enhance Allograft Wedge Instrument Tray | Conmed Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KCT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KCT device
- #1 K214041 Aesculap AICON Containerscore 18.1 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| 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 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090560 | Conmed Linvatec Anodized Aluminum Sterilization Trays | 2009 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090560 (Conmed Linvatec, 2009) has gone furthest, with 1 descendant of its own.
How does its category compare?
All KCT devicesKCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · KCT
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KCT
205in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KCT
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KCT
50in 2025
MAUDE reports naming product code KCT, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 199 | 0 | 2 |
| 2008 | 6 | 182 | 0 | 8 |
| 2009 | 6 | 89 | 0 | 5 |
| 2010 | 12 | 202 | 1 | 3 |
| 2011 | 6 | 117 | 2 | 3 |
| 2012 | 10 | 236 | 0 | 2 |
| 2013 | 8 | 131 | 1 | 6 |
| 2014 | 11 | 169 | 1 | 5 |
| 2015 | 15 | 151 | 0 | 6 |
| 2016 | 12 | 182 | 3 | 16 |
| 2017 | 10 | 211 | 1 | 3 |
| 2018 | 15 | 192 | 0 | 22 |
| 2019 | 18 | 187 | 0 | 15 |
| 2020 | 14 | 134 | 0 | 66 |
| 2021 | 18 | 185 | 1 | 26 |
| 2022 | 11 | 137 | 17 | 8 |
| 2023 | 10 | 94 | 0 | 30 |
| 2024 | 8 | 106 | 0 | 18 |
| 2025 | 11 | 205 | 0 | 50 |
| 2026 | 9 | 122 | 0 | — |
What is it indicated for?
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…
Read the full statement (191 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080531 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080531: Conmed Linvatec Microfracture Instrument Sterilization Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080531
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026