510(k) · Cleared
ClearedSynthes (Usa) 3.5MM LCP Hook Plate
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 Nov 7, 2008 after a 108-day review. The FDA summary names its predicate without a number. 36 later devices descend from it.
- Decided
- Nov 7, 2008
- Review
- 108 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
36 later devices descend from it, 7 citing it directly.
- This deviceK082072 Synthes (Usa) 3.5MM LCP Hook PlateSynthes (Usa) · 2008
- Descendant · cites it directly · 18 of its ownK143394 Acumed Small Fragment Base SetAcumed, LLC · 2015
- Descendant · 2 generations on · 15 of its ownK151886 Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015
- Descendant · 3 generations on · 14 of its ownK181113 CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018
- Descendant · 4 generations on · 6 of its ownK191535 CoLink® Mini Plating SystemIn2bones USA, LLC · 2019
- Descendant · cites it directly · 4 of its ownK233665 DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT…DePuy Synthes · 2024
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K143394Acumed Small Fragment Base SetAcumed, LLC · 2015 · cites it directly18descendants
- K151886Acumed Ankle and Small Fragment Base Set UpdateAcumed, LLC · 2015 · 2 generations on15descendants
- K181113CoLink™ Afx Plating SystemIn2bones USA, LLC · 2018 · 3 generations on14descendants
- K191535CoLink® Mini Plating SystemIn2bones USA, LLC · 2019 · 4 generations on6descendants
- K233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment…DePuy Synthes · 2024 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K082072 | Synthes (Usa) 3.5MM LCP Hook Plate | Synthes (Usa) | 2008 | — |
| +1 | K143394 | Acumed Small Fragment Base Set | Acumed, LLC | 2015 | — |
| +2 | K151886 | Acumed Ankle and Small Fragment Base Set Update | Acumed, LLC | 2015 | — |
| +3 | K181113 | CoLink™ Afx Plating System | In2bones USA, LLC | 2018 | — |
| +4 | K191535 | CoLink® Mini Plating System | In2bones USA, LLC | 2019 | — |
| +1 | K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small… | DePuy Synthes | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 3 | 0 |
| 2021 | 5 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 6 | 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? (1)
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 One-Third Tubular DCL Plate Named without a submission number |
What descends from it? (36)
See all 367 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143394 | Acumed Small Fragment Base Set | 2015 | 18 |
| K233665 | DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment… | 2024 | 4 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K223118 | OIC Variable Angle Small Fragment Locking Plate System | 2023 | 1 |
| K182650 | Arzzt Distal Radius and Ulna System | 2019 | 1 |
| K162829 | Medline UNITE® Ankle Fracture Plating System | 2016 | 1 |
| 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?
- Of its descendants, K143394 (Acumed, LLC, 2015) has gone furthest, with 18 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. 2008, 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?
Synthes 3.5mm LCP Hook Plate is indicated for fractures, osteotomies and non-unions of small bones including the ulna, radius, tibia and fibula, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082072 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082072: Synthes (Usa) 3.5MM LCP Hook Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082072
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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