510(k) · Cleared
ClearedSynthes (Usa) 1.5MM Mini Fragment LCP 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 Apr 1, 2009 after an 84-day review. The FDA summary names its predicate without a number. 1 of the 206 devices in its family, counting itself, has a Class I recall. 205 later devices descend from it.
- Decided
- Apr 1, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
205 later devices descend from it, 18 citing it directly. 1 of the 206 devices in this family, counting this one, has a Class I recall.
- This deviceK090047 Synthes (Usa) 1.5MM Mini Fragment LCP SystemSynthes (Usa) · 2009
- Descendant · cites it directly · 135 of its ownK112885 Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 79 of its ownK143039 CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
- Descendant · 3 generations on · 74 of its ownK162825 CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017
- Descendant · 4 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 5 generations on · 42 of its ownK191100 ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 205 · See all- K112885Zimmer Plates and Screws System Screws OnlyZimmer, Inc. · 2011 · cites it directly135descendants
- K143039CrossRoads Screw SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 2 generations on79descendants
- K162825CAPTIVATE™ Compression ScrewsGlobus Medical, Inc. · 2017 · 3 generations on74descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 4 generations on69descendants
- K191100ExcelsiusGPS Spine 1.1 Interbody ModuleGlobus Medical, Inc. · 2019 · 5 generations on42descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090047 | Synthes (Usa) 1.5MM Mini Fragment LCP System | Synthes (Usa) | 2009 | — |
| +1 | K112885 | Zimmer Plates and Screws System Screws Only | Zimmer, Inc. | 2011 | 15 |
| +2 | K143039 | CrossRoads Screw System | Orthodiscovery Group, LLC (D.B.A. Crossroads Extrem | 2015 | — |
| +3 | K162825 | CAPTIVATE™ Compression Screws | Globus Medical, Inc. | 2017 | — |
| +4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +5 | K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 8 | 0 |
| 2015 | 12 | 0 |
| 2016 | 2 | 0 |
| 2017 | 11 | 0 |
| 2018 | 6 | 0 |
| 2019 | 10 | 0 |
| 2020 | 12 | 0 |
| 2021 | 10 | 1 |
| 2022 | 14 | 0 |
| 2023 | 22 | 0 |
| 2024 | 32 | 0 |
| 2025 | 28 | 0 |
| 2026 | 33 | 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 Modular Mini Fragment LCP System Named without a submission number | |
| * | — | Synthes Stainless Steel Modular Hand System Named without a submission number |
What descends from it? (205)
See all 20518 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112885 | Zimmer Plates and Screws System Screws Only | 2011 | 135 |
| K171904 | Tandry Locking Plate System | 2018 | 11 |
| K180554 | ANTHEM Fracture System | 2018 | 10 |
| K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless… | 2012 | 9 |
| K143050 | VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws | 2014 | 8 |
| K142419 | Mini and Micro Fragments Reconstruction System-NEOFIX | 2014 | 8 |
| K141527 | Depuy Synthes Variable Angle Locking Hand System | 2015 | 7 |
| K171808 | TDM Plate and Screw System | 2018 | 6 |
| K110086 | Ifs Profile Plates, Screws, and Washers | 2011 | 5 |
| K161894 | SurgTech Trauma System | 2017 | 3 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K112885 (Zimmer, Inc., 2011) has gone furthest, with 135 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. 2009, 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 1.5mm Mini Fragment LCP System is indicated for fixation of small bones and small fragments, osteotomies, arthrodeses, replantations, and reconstructions of small bones and small fragments, particularly in osteopenic bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090047: Synthes (Usa) 1.5MM Mini Fragment LCP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090047
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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