510(k) · Cleared
ClearedSynthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP)
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 17, 2009 as substantially equivalent to K082807 (Synthes (Usa), 2008) after an 84-day review. Its family tree reaches back 4 generations to 1998. 51 later devices descend from it.
- Decided
- Nov 17, 2009
- Review
- 84 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K981372 (1998). 12 ancestors in all. 51 later devices descend from it, 11 citing it directly.
- Root · 4 generations backK981372 Synthes 3.0 MM PC-Fix SystemSynthes (Usa) · 1998
- 3 generations backK991407 Synthes Locking Calcaneal PlatesSynthes (Usa) · 1999
- 2 generations backK033669 Smith & Nephew Locking Bone Plate System (Locking Bone Plates and…Smith & Nephew, Inc. · 2003 · Recalled
- 1 generation backK082807 Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with…Synthes (Usa) · 2008
- This deviceK092609 Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking…Synthes (Usa) · 2009
- Descendant · cites it directly · 14 of its ownK123562 Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · Recalled
- Descendant · 2 generations on · 11 of its ownK131657 Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · Recalled
- Descendant · cites it directly · 11 of its ownK113733 Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012
- Descendant · 2 generations on · 8 of its ownK142419 Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014
- Descendant · 2 generations on · 7 of its ownK152306 MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015
Showing 5 of 51 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 51 · See all- K123562Flower Small and Medium Bone ImplantsFlower Orthopedics Corporation · 2013 · cites it directly14descendants
- K131657Flower Small and Medium Implant SetFlower Orthopedics Corporation · 2013 · 2 generations on11descendants
- K113733Small and Large Fragments Osteosynthesis System NeofixNeoortho Produtos Ortopedicos S/A · 2012 · cites it directly11descendants
- K142419Mini and Micro Fragments Reconstruction System-NEOFIXNeoortho Productos Orthopedicos S/A · 2014 · 2 generations on8descendants
- K152306MotoBand¿ CP Implant SystemCrossroads Extremity Systems, LLC · 2015 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K981372 | Synthes 3.0 MM PC-Fix System | Synthes (Usa) | 1998 | — |
| −3 | K991407 | Synthes Locking Calcaneal Plates | Synthes (Usa) | 1999 | — |
| −2 | K033669 | Smith & Nephew Locking Bone Plate System (Locking Bone Plates and Screws) | Smith & Nephew, Inc. | 2003 | 1 |
| −1 | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded… | Synthes (Usa) | 2008 | — |
| 0 (this device) | K092609 | Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates… | Synthes (Usa) | 2009 | — |
| +1 | K123562 | Flower Small and Medium Bone Implants | Flower Orthopedics Corporation | 2013 | 2 |
| +2 | K131657 | Flower Small and Medium Implant Set | Flower Orthopedics Corporation | 2013 | 1 |
| +1 | K113733 | Small and Large Fragments Osteosynthesis System Neofix | Neoortho Produtos Ortopedicos S/A | 2012 | — |
| +2 | K142419 | Mini and Micro Fragments Reconstruction System-NEOFIX | Neoortho Productos Orthopedicos S/A | 2014 | — |
| +2 | K152306 | MotoBand¿ CP Implant System | Crossroads Extremity Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2022 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 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 |
|---|---|---|---|
| * | K082807 | Synthes (Usa) 3.5 and 4.5 MM Locking Compression Plate System with Expanded IndicationsSummary page 1…and accessories Predicate Device: Synthes 3.5 mm and 4.5 mm Locking Compression Plate (LCP) System with Expanded Indications (K082807) Device Description: The Synthes Curved Narrow and Broad LCP Plates are available in sta… | 2008 |
What descends from it? (51)
See all 5111 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123562 | Flower Small and Medium Bone Implants | 2013 | 14 |
| K113733 | Small and Large Fragments Osteosynthesis System Neofix | 2012 | 11 |
| K180310 | DePuy Synthes Trauma Orthopedic Plates and Screws | 2018 | 4 |
| K112085 | Synthes LCP Pediatric Plate Systems | 2011 | 4 |
| K152000 | SMV Scientific Bone Plate and Screw System | 2015 | 3 |
| K171320 | ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS… | 2018 | 2 |
| K153374 | CARE BRAND Locking Bone Plates and Screws Osteosynthesis Plating System, CARE Brand of… | 2016 | 1 |
| K141680 | AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN… | 2015 | 1 |
| K243469 | Signex | 2025 | 0 |
| K201229 | Intai Anatomic Locking Plate and Screw System | 2022 | 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 4.5 years on median.
- 3 of the 12 ancestors have a recall of any class.
- Of its descendants, K123562 (Flower Orthopedics Corporation, 2013) has gone furthest, with 14 descendants of its own.
- 42 other devices also cite its predicate K082807.
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?
The Synthes 3.5mm Curved Narrow and Broad LCP Plates are intended for fixation of fractures, osteotomies and non-unions of clavicle, scapula, olecranon, humerus, radius, pelvis, distal tibia and fibula, particularly in osteopenic bone for adult patients.
The Synthes 4.5mm Curved Narrow and Broad LCP Plates are intended for fixation of various long bones, such as the humerus, femur, and tibia. They are also for use in fixation of periprosthetic fractures, osteopenic bone, and non-unions or malunions in adult patients.
The 3.5mm and 4.5mm Curved Narrow and Broad LCP Plates are also indicated for fracture fixation of diaphyseal and metaphyseal areas of long bones in pediatric patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092609 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092609: Synthes 3.5 MM and 4.55 MM Curved Narrow and Broad Locking Compression Plates (LCP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092609
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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