510(k) · Cleared
ClearedConmed Linvatec Anodized Aluminum Sterilization Trays
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 Jun 29, 2009 as substantially equivalent to K080531 (Conmed Linvatec, 2008) after a 119-day review. Its family tree reaches back 1 generation to 2008. 1 later device descends from it.
- Decided
- Jun 29, 2009
- Review
- 119 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080531 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK080531 Conmed Linvatec Microfracture Instrument Sterilization TrayConmed Linvatec · 2008
- This deviceK090560 Conmed Linvatec Anodized Aluminum Sterilization TraysConmed Linvatec · 2009
- Descendant · cites it directly · 0 of its ownK152969 Enhance Allograft Wedge Instrument TrayConmed Corporation · 2016
Most influential descendants
Showing 1 of 1 · See all- K152969Enhance Allograft Wedge Instrument TrayConmed Corporation · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K080531 | Conmed Linvatec Microfracture Instrument Sterilization Tray | Conmed Linvatec | 2008 | — |
| 0 (this device) | K090560 | Conmed Linvatec Anodized Aluminum Sterilization Trays | Conmed Linvatec | 2009 | — |
| +1 | K152969 | Enhance Allograft Wedge Instrument Tray | Conmed Corporation | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080531 | Conmed Linvatec Microfracture Instrument Sterilization TraySummary page 1…KCT Predicate Device ConMed Linvatec Microfracture Instrument Sterilization Tray (MFX-TRAY), K080531 Device Description ConMed Linvatec Anodized Aluminum Sterilization Trays are constructed of metal with perforations to facilitat… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152969 | Enhance Allograft Wedge Instrument Tray | 2016 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K152969 (Conmed Corporation, 2016) has gone furthest, with 0 descendants 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. 2009, 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?
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of containment devices for medical device sterilization. The PowerPro® Small System Sterilization Case (PRO5095) and the Hall® Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed Linvatec handpieces as well as attachments and/or accessories that may be used with the powered handpieces. Cannulated handpieces or attachments with an internal diameter not less than…
Read the full statement (327 words)
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of
containment devices for medical device sterilization.
The PowerPro® Small System Sterilization Case (PRO5095) and the Hall®
Sterilization Tray (PRO6000) are designed to hold a variety of powered ConMed
Linvatec handpieces as well as attachments and/or accessories that may be
used with the powered handpieces.
Cannulated handpieces or attachments with an internal diameter not less than
0.031 inches (0.079cm) and a cannulated length no greater than 5.75 inches
(14.61cm) and/or handpiece accessories such as pneumatic air supply hoses
with a lumen not less than 0.187 inches (0.475 cm) in diameter and a cannulated
length no greater than 15 feet (4.6 m) may be sterilized in this tray along with
other non-cannulated, non-porous instruments.
Sterilize the PowerPro® Small System Sterilization Case (PRO5095) and the
Hall® Sterilization Tray (PRO6000) using the following parameters.
Steam (wrapped), Pre-vacuum: 2700 F(1320C), 4 minutes exposure, 25 minutes dry cycle
Steam (wrapped), Gravity: 270°F(132 0C), 15 minutes exposure, 35 minutes dry cycle
CAUTION: Testing demonstrates that a minimum dry time of 35 minutes is required to prevent
wet packs when using the gravity cycle.
ConMed Linvatec Anodized Aluminum Sterilization Trays is a family of
containment devices for medical device sterilization.
The Hip Arthroscopy Master Tray is intended for use only with the following
instruments:
S210GSP Grasping Forceps 25.50014EL EL Liberator
S21 OSRF Suture Retrieval 25.50016EL EL Rasp
S21 0MSC Micro-scissors 06105SEL EL Crochet Hook.
S21 OAFU Aggressor Forcep Up 8748EL EL Knot Pusher
S21 OAFL Aggressor Forcep Left 9837 EL Hip Obturator
S21 0AFR Aggressor Forcep Right A55-01 2-022 BMR Obturator, Blunt
S21 0RFR Rotary Forcep Right A55-01 2-023 BMR Obturator, Trocar
S210RGF Retrograde Forceps A55-012-113 BMR Drill Bit
S21 ORFL Rotary- Forcep Left A55&01 2-130 ~BMR Bone. Punch
C6171 EL EL Dril Guide Fishmouth A55-012-120 BMR Tap
C61 72EL EL DrIl Guide Serrated GU1009EL EL Katana
SC7900 Sloted Hip Cannula, 6.7mm GU1004EL EL Raven, Straight
SC6900 Slotted Hip Cannula, 5.0mm 21.1001 EL EL Probe
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090560 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090560: Conmed Linvatec Anodized Aluminum Sterilization Trays.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090560
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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