510(k) · Cleared
ClearedEnhance Allograft Wedge Instrument Tray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
Cleared on Mar 31, 2016 as substantially equivalent to K090560 (Conmed Linvatec, 2009) after a 175-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Mar 31, 2016
- Review
- 175 days
- Class
- Class II
- Product code
- KCT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K080531 (2008). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K090560 | Conmed Linvatec Anodized Aluminum Sterilization TraysSummary page 4…Device Name: ConMed Linvatec Anodized Aluminum Sterilization Trays Company Name: ConMed Linvatec 510(k) #: K090560 IV. DEVICE DESCRIPTION The Enhance® Allograft Wedge Instrumentation Tray (T903) is constructed primarily of al… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 6.8 years on median.
- None of the 2 ancestors has a recall.
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. 2016, 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 Enhance Allograft Wedge Instrumentation Tray (T903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments: REF Description REF Description 903106 Evans Trial 6mm 903206 Cotton Trial 6mm 903108…
Read the full statement (224 words)
The Enhance Allograft Wedge Instrumentation Tray (T903) is a containment device intended for medical device sterilization. The Enhance Allograft Wedge Instrumentation Tray is used for loading surgical instruments in order to conveniently organize, sterilize, transport, and store the instruments between uses. This tray is intended for use with the following instruments:
REF Description REF Description
903106 Evans Trial 6mm 903206 Cotton Trial 6mm
903108 Evans Trial 8mm 903207 Cotton Trial 7mm
903110 Evans Trial 10mm 903208 Cotton Trial 8mm
903112 Evans Trial 12mm 903006 Mallet
903010 Tamp Evans 903008 Distractor
903012 Tamp Cotton 903002 Osteotome 16mm
903205 Cotton Trial 5mm 903004 Osteotome 10mm
The Enhance Allograft Wedge Instrumentation Tray (T903) 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 medical instruments. Sterilize the instrument tray using the following sterilization parameters:
Method Cycle Temperature Exposure Dry Cycle Cool Down Duration
Steam Pre-vacuum 270°F (132°C) 4 minutes 20 minutes 118°F (48°C) 25 minutes (wrapped)
Steam Gravity 250°F (121°C) 30 minutes 15 minutes 118°F (48°C) 37 minutes (wrapped)
- Validation was conducted using an FDA cleared sterilization wrap with a maximum load 14 lbs. (6.4 kg).
- Only single unstacked trays may be used during the sterilization process.
- Double wrap tray using an FDA cleared wrap.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K152969 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152969: Enhance Allograft Wedge Instrument Tray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152969
Report an extraction error
Are you the manufacturer?
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