510(k) · Cleared
ClearedSynthes 3.5MM LCP Clavicle Plate System
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 Aug 8, 2011 as substantially equivalent to K101536 (Synthes (Usa), LLC, 2010) and 2 other predicates after a 67-day review. Its family tree reaches back 2 generations to 2000. 45 later devices descend from it.
- Decided
- Aug 8, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000684 (2000). 3 ancestors in all. 45 later devices descend from it, 10 citing it directly.
- Root · 2 generations backK000684 Small Fragment Dynamic Compression Locking (DCL) SystemSynthes (Usa) · 2000 · Recalled
- 1 generation backK101536 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSynthes (Usa), LLC · 2010
- This deviceK111540 Synthes 3.5MM LCP Clavicle Plate SystemSynthes (Usa) · 2011
- Descendant · cites it directly · 11 of its ownK173166 ANTHEM Fracture SystemGlobus Medical, Inc. · 2017
- Descendant · 2 generations on · 10 of its ownK180554 ANTHEM Fracture SystemGlobus Medical, Inc. · 2018
- Descendant · cites it directly · 8 of its ownK213864 Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022
- Descendant · 2 generations on · 8 of its ownK202496 ANTHEM Fracture SystemGlobus Medical, Inc. · 2020
- Descendant · 2 generations on · 7 of its ownK231292 TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal…Bonebridge AG · 2023
Showing 5 of 45 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 45 · See all- K173166ANTHEM Fracture SystemGlobus Medical, Inc. · 2017 · cites it directly11descendants
- K180554ANTHEM Fracture SystemGlobus Medical, Inc. · 2018 · 2 generations on10descendants
- K213864Bonebridge Osteosynthesis Plating SystemBonebridge AG · 2022 · cites it directly8descendants
- K202496ANTHEM Fracture SystemGlobus Medical, Inc. · 2020 · 2 generations on8descendants
- K231292TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia System; LORRAINE…Bonebridge AG · 2023 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000684 | Small Fragment Dynamic Compression Locking (DCL) System | Synthes (Usa) | 2000 | 1 |
| −1 | K101536 | 2.7/3.5MM VA-LCP Anteriro Clavicle Plate System | Synthes (Usa), LLC | 2010 | — |
| 0 (this device) | K111540 | Synthes 3.5MM LCP Clavicle Plate System | Synthes (Usa) | 2011 | — |
| +1 | K173166 | ANTHEM Fracture System | Globus Medical, Inc. | 2017 | — |
| +2 | K180554 | ANTHEM Fracture System | Globus Medical, Inc. | 2018 | — |
| +1 | K213864 | Bonebridge Osteosynthesis Plating System | Bonebridge AG | 2022 | — |
| +2 | K202496 | ANTHEM Fracture System | Globus Medical, Inc. | 2020 | — |
| +2 | K231292 | TAMINA 3.5mm Proximal Humerus System; POYA 3.5MM Lateral Proximal Tibia… | Bonebridge AG | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 12 | 0 |
| 2025 | 7 | 0 |
| 2026 | 8 | 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 HRS? 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? (3)
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 |
|---|---|---|---|
| * | K101536 | 2.7/3.5MM VA-LCP Anteriro Clavicle Plate SystemSummary page 1…tiple component metallic bone fixation appliance and accessories. Predicate Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System (1(101536) Devices: Synthes 3.5mm LCP Clavicle Plate System (K073186) Synthes Small Fragment Dynamic Co… | 2010 |
| * | K073186 | Synthes 3.5MM LCP Clavicle Plate SystemSummary page 1…and accessories. Predicate Synthes 2.7/3.5mm VA-LCP Anterior Clavicle Plate System (1(101536) Devices: Synthes 3.5mm LCP Clavicle Plate System (K073186) Synthes Small Fragment Dynamic Compression Locking System (K000684) Device… | 2007 |
| * | K000684 | Small Fragment Dynamic Compression Locking (DCL) SystemSummary page 1…es: Synthes 3.5mm LCP Clavicle Plate System (K073186) Synthes Small Fragment Dynamic Compression Locking System (K000684) Device The Synthes 3.5mm LCP Clavicle Plate System consists of metallic Description: plates and screws… | 2000 |
What descends from it? (45)
See all 4510 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173166 | ANTHEM Fracture System | 2017 | 11 |
| K213864 | Bonebridge Osteosynthesis Plating System | 2022 | 8 |
| K192984 | APTUS Clavicle System | 2020 | 6 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K201321 | DePuy Synthes 2.7mm VA LCP Clavicle Plate System | 2020 | 3 |
| K191793 | Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand… | 2019 | 3 |
| K163383 | GREENS BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, GREENS BRAND… | 2017 | 3 |
| K222282 | HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System | 2022 | 1 |
| K260761 | APTUS Clavicle System 2.8 | 2026 | 0 |
| K243469 | Signex | 2025 | 0 |
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?
- The line of descent spans 11 years and passes through 2 companies; a new generation was cleared every 10.4 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K173166 (Globus Medical, Inc., 2017) has gone furthest, with 11 descendants of its own.
- 4 other devices also cite its predicate K101536.
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
The Synthes 3.5mm LCP Clavicle Plate System is indicated for fixation of fractures, malunions, non-unions, and osteotomies of the clavicle in adults, and in both adolescents (12-18 years) and transitional adolescents (18-21 years), in which the clavicular growth plates have fused or in which the growth plates will not be crossed by the plate system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111540: Synthes 3.5MM LCP Clavicle Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111540
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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