510(k) · Cleared
ClearedMedoff Sliding Plate (Proposed Name)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wrightmedicaltechnologyinc · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Jan 22, 1997 after a 224-day review. The FDA summary names its predicate without a number.
- Decided
- Jan 22, 1997
- Review
- 224 days
- Class
- Class II
- Product code
- KTT
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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 KTT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
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What was it cleared against? (2)
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 |
|---|---|---|---|
| * | — | Axial Compression Screw Named without a submission number | |
| * | — | Hawaiian Supracondylar Plate Named without a submission number |
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.
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 9 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The indications for the sterile Medoff Sliding Plate System vary depending on the configuration of the bone plate. Fracture configurations which lend themselves to the general principle of axial compression should be those that are selected for use with this device. The use of the 4-hole or the 6-hole plating system depends upon surgeon preference and the selection is more related to the size of the surgical exposure and how far down the shaft the…
Read the full statement (177 words)
The indications for the sterile Medoff Sliding Plate System vary depending on the configuration of the bone plate. Fracture configurations which lend themselves to the general principle of axial compression should be those that are selected for use with this device. The use of the 4-hole or the 6-hole plating system depends upon surgeon preference and the selection is more related to the size of the surgical exposure and how far down the shaft the fracture extends.
Specific indications for the 135 degree 4-hole standard plate design or 6-hole standard plate design include the following fracture configurations:
Basicervical fractures of the femur
Intertrochanteric fractures of the femur.
Unstable intertrochanteric fractures of the femur.
High subtrochanteric fractures of the femur just distal to the level of the lesser trochanter.
Specific indications for the supracondylar plate design include the following fracture configurations:
Low transverse or short oblique supracondylar fractures of the distal femur.
T condylar fractures of the femur that can be converted to low transverse or short oblique supracondylar fractures by rigid fixation of condylar fragments with screws.
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/K962251 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962251: Medoff Sliding Plate (Proposed Name).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K962251
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026