510(k) · Cleared
ClearedSynthes (Usa) LCP Proximal Humerus Plates, Long
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HRS Plate, Fixation, Bone
Cleared on Sep 8, 2004 after a 61-day review. The FDA summary names its predicate without a number. 1 of the 655 devices in its family, counting itself, has a Class I recall. 654 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 61 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
654 later devices descend from it, 36 citing it directly. 1 of the 655 devices in this family, counting this one, has a Class I recall.
- This deviceK041860 Synthes (Usa) LCP Proximal Humerus Plates, LongSynthes (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 654 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 654 · 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) | K041860 | Synthes (Usa) LCP Proximal Humerus Plates, Long | 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 | 2 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 5 | 0 |
| 2010 | 10 | 0 |
| 2011 | 15 | 0 |
| 2012 | 20 | 0 |
| 2013 | 14 | 0 |
| 2014 | 32 | 0 |
| 2015 | 37 | 0 |
| 2016 | 27 | 0 |
| 2017 | 48 | 0 |
| 2018 | 27 | 0 |
| 2019 | 36 | 0 |
| 2020 | 41 | 0 |
| 2021 | 48 | 1 |
| 2022 | 39 | 0 |
| 2023 | 48 | 0 |
| 2024 | 62 | 0 |
| 2025 | 59 | 0 |
| 2026 | 74 | 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 HRS device
- #1 K222465 Tyber Medical Anatomical Plating Systemscore 27.5 · 16 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 LCP Proximal Humerus Plates Named without a submission number | |
| * | — | Synthes Small Fragment DCL System Named without a submission number |
What descends from it? (654)
See all 65436 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 |
| K143138 | AxSOS 3 Ti Locking Plate System | 2014 | 26 |
| K062494 | Ebi Optilock Upper Extremity Plating System | 2006 | 22 |
| K121672 | Aft Proximal Humerus Fracture Plate | 2012 | 20 |
| K103002 | Synthes Multiloc Proximal Humeral Nailing System | 2011 | 17 |
| K153716 | GPC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System. | 2016 | 15 |
| K102597 | Piccolo Composite Plate System | 2011 | 15 |
| K163361 | ANTHEM™ Fracture System | 2017 | 14 |
| K113733 | Small and Large Fragments Osteosynthesis System Neofix | 2012 | 11 |
| K130108 | Double Engine Bone Plate and Screw Systems | 2013 | 9 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HRS
54in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HRS
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HRS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HRS
2,306in 2025
MAUDE reports naming product code HRS, 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 | 35 | 63 | 2 | 339 |
| 2008 | 35 | 87 | 11 | 311 |
| 2009 | 47 | 85 | 3 | 435 |
| 2010 | 49 | 100 | 16 | 491 |
| 2011 | 43 | 88 | 5 | 773 |
| 2012 | 59 | 106 | 4 | 1,663 |
| 2013 | 56 | 89 | 11 | 2,643 |
| 2014 | 76 | 57 | 0 | 2,413 |
| 2015 | 56 | 97 | 7 | 3,095 |
| 2016 | 44 | 109 | 5 | 2,276 |
| 2017 | 57 | 122 | 3 | 2,220 |
| 2018 | 40 | 116 | 2 | 2,663 |
| 2019 | 46 | 89 | 25 | 3,359 |
| 2020 | 48 | 88 | 1 | 2,790 |
| 2021 | 40 | 87 | 9 | 2,442 |
| 2022 | 47 | 144 | 3 | 1,700 |
| 2023 | 40 | 120 | 1 | 2,049 |
| 2024 | 54 | 96 | 0 | 1,849 |
| 2025 | 54 | 90 | 1 | 2,306 |
| 2026 | 51 | 82 | 3 | — |
What is it indicated for?
Synthes (USA) LCP Proximal Humerus Plate, long is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041860 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041860: Synthes (Usa) LCP Proximal Humerus Plates, Long.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041860
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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