510(k) · Cleared
ClearedSynthes LCP Proximal Humerus Plates
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 Sep 6, 2001 after an 87-day review. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate. 185 later devices descend from it.
- Decided
- Sep 6, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- KTW
- Recalls
- None
- Predicates
- 0
185 later devices descend from it, 25 citing it directly.
- This deviceK011815 Synthes LCP Proximal Humerus PlatesSynthes (Usa) · 2001
- Descendant · cites it directly · 77 of its ownK083032 Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · Recalled
- Descendant · cites it directly · 68 of its ownK042695 NCB Plating SystemZimmer GmbH · 2004 · Recalled
- Descendant · 2 generations on · 46 of its ownK132886 Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 33 of its ownK123055 Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013
- Descendant · 3 generations on · 32 of its ownK140814 Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · Recalled
Showing 5 of 185 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 185 · See all- K083032Peri-Loc Bone Plating and Screw SystemSmith & Nephew, Inc. · 2009 · cites it directly77descendants
- K042695NCB Plating SystemZimmer GmbH · 2004 · cites it directly68descendants
- K132886Smith & Nephew Variable-Angle Locking Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 2 generations on46descendants
- K123055Smith & Nephew, Inc Screw and Plate System InstrumentationSmith & Nephew, Inc. · 2013 · 2 generations on33descendants
- K140814Evos Mini-Fragment Plating SystemSmith & Nephew, Inc. · 2014 · 3 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K011815 | Synthes LCP Proximal Humerus Plates | Synthes (Usa) | 2001 | — |
| +1 | K083032 | Peri-Loc Bone Plating and Screw System | Smith & Nephew, Inc. | 2009 | 2 |
| +1 | K042695 | NCB Plating System | Zimmer GmbH | 2004 | 1 |
| +2 | K132886 | Smith & Nephew Variable-Angle Locking Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
| +2 | K123055 | Smith & Nephew, Inc Screw and Plate System Instrumentation | Smith & Nephew, Inc. | 2013 | — |
| +3 | K140814 | Evos Mini-Fragment Plating System | Smith & Nephew, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 8 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 0 |
| 2017 | 15 | 0 |
| 2018 | 11 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 8 | 0 |
| 2023 | 16 | 0 |
| 2024 | 21 | 0 |
| 2025 | 15 | 0 |
| 2026 | 16 | 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 Fragment Dynamic Compression Locking (DCL) System Named without a submission number | |
| * | — | De Puy Ace Symmetry Proximal Humerus Plate Named without a submission number |
What descends from it? (185)
See all 18525 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083032 | Peri-Loc Bone Plating and Screw System | 2009 | 77 |
| K042695 | NCB Plating System | 2004 | 68 |
| K062494 | Ebi Optilock Upper Extremity Plating System | 2006 | 22 |
| K121672 | Aft Proximal Humerus Fracture Plate | 2012 | 20 |
| K102597 | Piccolo Composite Plate System | 2011 | 15 |
| K163361 | ANTHEM™ Fracture System | 2017 | 14 |
| K213864 | Bonebridge Osteosynthesis Plating System | 2022 | 8 |
| K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE… | 2023 | 7 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K093978 | Exactech Equinoxe Proximal Humerus Fracture Plate System | 2010 | 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, K083032 (Smith & Nephew, Inc., 2009) has gone furthest, with 77 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 LCP Proximal Humerus Plate is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
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/K011815 · printed Nov 6, 2026
Cite this page
510(k) Report. “K011815: Synthes LCP Proximal Humerus Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K011815
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026