510(k) · Cleared
Cleared3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated LC-Abp)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Cleared on Oct 25, 1999 after a 63-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Oct 25, 1999
- Review
- 63 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK992837 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90…Synthes (Usa) · 1999
- Descendant · cites it directly · 4 of its ownK180310 DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018
- Descendant · 2 generations on · 1 of its ownK243995 Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025
- Descendant · 2 generations on · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK260353 Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage…Arthrex, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK241128 TDM Plate and Screw SystemTdm Co., Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K180310DePuy Synthes Trauma Orthopedic Plates and ScrewsSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. · 2018 · cites it directly4descendants
- K243995Arthrex Humeral Plating System and Cerclage ButtonArthrex, Inc. · 2025 · 2 generations on1descendant
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · 2 generations on1descendant
- K260353Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage ButtonArthrex, Inc. · 2026 · 2 generations on0descendants
- K241128TDM Plate and Screw SystemTdm Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992837 | 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated… | Synthes (Usa) | 1999 | — |
| +1 | K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. | 2018 | — |
| +2 | K243995 | Arthrex Humeral Plating System and Cerclage Button | Arthrex, Inc. | 2025 | — |
| +2 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
| +2 | K260353 | Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button | Arthrex, Inc. | 2026 | — |
| +3 | K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 KTW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | — | Synthes Small T-Plate Named without a submission number | |
| * | — | Ace DePuy Symmetry Proximal Humerus Plate Named without a submission number |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
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, K180310 (Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc., 2018) has gone furthest, with 4 descendants of its own.
How does its category compare?
All KTW devicesKTW Appliance, Fixation, Nail/Blade/Plate Combination, Single Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTW
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · KTW
Too few KTW 510(k)s in any year since 2007 to give a median.
Recalls per year · KTW
57in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTW
96in 2025
MAUDE reports naming product code KTW, 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 | 0 | — | 0 | 3 |
| 2008 | 2 | — | 0 | 10 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 57 | 26 |
| 2011 | 0 | — | 0 | 21 |
| 2012 | 1 | — | 0 | 70 |
| 2013 | 0 | — | 0 | 70 |
| 2014 | 0 | — | 0 | 62 |
| 2015 | 0 | — | 0 | 26 |
| 2016 | 1 | — | 0 | 41 |
| 2017 | 2 | — | 0 | 27 |
| 2018 | 0 | — | 0 | 24 |
| 2019 | 1 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 60 |
| 2021 | 0 | — | 0 | 25 |
| 2022 | 0 | — | 0 | 50 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 0 | — | 0 | 123 |
| 2025 | 0 | — | 0 | 96 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Synthes 3.5 mm 90° Cannulated Limited Contact Angled Blade Plates are intended for the fixation of fractures and non-unions of the proximal humerus and distal tibia.
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/K992837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992837: 3.5 MM 90 Cannulated Limited Contact Angeled Blade Plates (3.5MM 90 Cannulated LC-Abp).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992837
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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