510(k) · Cleared
Recalled · Class II · 20133.5 MM LCP Distal Humerus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Mar 1, 2004 after a 68-day review. The FDA summary names its predicate without a number. 1 of the 625 devices in its family, counting itself, has a Class I recall. 624 later devices descend from it. It has been recalled once.
- Decided
- Mar 1, 2004
- Review
- 68 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 1
- Predicates
- 0
624 later devices descend from it, 24 citing it directly. 1 of the 625 devices in this family, counting this one, has a Class I recall.
- This deviceK033995 3.5 MM LCP Distal Humerus SystemSynthes (Usa) · 2004
- Descendant · cites it directly · 584 of its ownK051735 Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper…Smith & Nephew, Inc. · 2005
- Descendant · 2 generations on · 495 of its ownK071563 Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007
- Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · 4 generations on · 228 of its ownK100776 Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010
- Descendant · 4 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
Showing 5 of 624 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 624 · See all- K051735Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper ExtremitySmith & Nephew, Inc. · 2005 · cites it directly584descendants
- K071563Peri-Loc Periarticular Locked Plating SystemSmith & Nephew, Inc. · 2007 · 2 generations on495descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
- K100776Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot SystemSynthes (Usa) · 2010 · 4 generations on228descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 4 generations on161descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033995 | 3.5 MM LCP Distal Humerus System | Synthes (Usa) | 2004 | — |
| +1 | K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | Smith & Nephew, Inc. | 2005 | — |
| +2 | K071563 | Peri-Loc Periarticular Locked Plating System | Smith & Nephew, Inc. | 2007 | — |
| +3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +4 | K100776 | Synthes 2.4 MM/2.7 MM Variable Angle LCP Forefoot/Midfoot System | Synthes (Usa) | 2010 | — |
| +4 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 14 | 0 |
| 2012 | 15 | 0 |
| 2013 | 12 | 0 |
| 2014 | 30 | 0 |
| 2015 | 32 | 0 |
| 2016 | 25 | 0 |
| 2017 | 48 | 0 |
| 2018 | 26 | 0 |
| 2019 | 35 | 0 |
| 2020 | 42 | 0 |
| 2021 | 46 | 1 |
| 2022 | 37 | 0 |
| 2023 | 47 | 0 |
| 2024 | 61 | 0 |
| 2025 | 57 | 0 |
| 2026 | 72 | 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.
1 device in this family has a Class I recall. 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 3.5 mm LCP Reconstruction Plate Named without a submission number | |
| * | — | Synthes 2.4 mm Cortex Screw, self-tapping Named without a submission number |
What descends from it? (624)
See all 62424 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051735 | Peri-Loc Locking Bone Plates and Locking Bone Screws for the Upper Extremity | 2005 | 584 |
| K120070 | Synthes Variable Angle LCP Elbow System | 2012 | 76 |
| K120717 | Synthes Variable Angle LCP Elbow System (Medical and Posterolateral Distal Humerus Plates) | 2012 | 53 |
| K062494 | Ebi Optilock Upper Extremity Plating System | 2006 | 22 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | 2016 | 15 |
| K080184 | Distal Humeral Plates with Angular Stability | 2008 | 15 |
| K113733 | Small and Large Fragments Osteosynthesis System Neofix | 2012 | 11 |
| K112560 | Aptus (R) Distal Humerus System | 2011 | 8 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 8, 2013 | Class II | Z-2278-2013 | Labeling mix-ups | Recall is being initiated due to the part being mislabeled (Part Number 241.267 was mislabeled with Part Number 241.276). |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K051735 (Smith & Nephew, Inc., 2005) has gone furthest, with 584 descendants of its own.
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 Synthes 3.5 mm LCP Distal Humerus System is indicated for intraarticular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.
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/K033995 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033995: 3.5 MM LCP Distal Humerus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033995
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