510(k) · Cleared
ClearedSynthes 3.5 MM Broad LC-DCP Plates
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 Jun 12, 2002 after an 86-day review. Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate. 7 later devices descend from it.
- Decided
- Jun 12, 2002
- Review
- 86 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK020872 Synthes 3.5 MM Broad LC-DCP PlatesSynthes (Usa) · 2002
- Descendant · cites it directly · 4 of its ownK031875 Inter-OS Limb LengthenerInter-Os Technologies · 2003
- Descendant · 2 generations on · 2 of its ownK192181 PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 0 of its ownK202348 External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · 3 generations on · 0 of its ownK193617 Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK133541 Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K031875Inter-OS Limb LengthenerInter-Os Technologies · 2003 · cites it directly4descendants
- K192181PRECICE Plating SystemNuvasive Specialized Orthopedics, Inc. · 2019 · 2 generations on2descendants
- K202348External Remote Controller ERC 4PNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on0descendants
- K193617Precice® ScrewsNuvasive Specialized Orthopedics, Inc. · 2020 · 3 generations on0descendants
- K133541Emerge Medical Small and Large Non-Locking Fragment Plate SystemEmerge Medical · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K020872 | Synthes 3.5 MM Broad LC-DCP Plates | Synthes (Usa) | 2002 | — |
| +1 | K031875 | Inter-OS Limb Lengthener | Inter-Os Technologies | 2003 | — |
| +2 | K192181 | PRECICE Plating System | Nuvasive Specialized Orthopedics, Inc. | 2019 | 1 |
| +3 | K202348 | External Remote Controller ERC 4P | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +3 | K193617 | Precice® Screws | Nuvasive Specialized Orthopedics, Inc. | 2020 | — |
| +1 | K133541 | Emerge Medical Small and Large Non-Locking Fragment Plate System | Emerge Medical | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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?
Our reading found no predicate number; beside “510(k)” the summary reads “000005”, which our checks could not confirm as its predicate.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K031875 (Inter-Os Technologies, 2003) has gone furthest, with 4 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?
The Synthes 3.5 mm Broad LC-DCP Plates are intended for use on the diaphysis of the long bones (i.e., humerus, ulna, and tibia).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020872 · printed Nov 4, 2026
Cite this page
510(k) Report. “K020872: Synthes 3.5 MM Broad LC-DCP Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K020872
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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