510(k) · Cleared
Recalled · Class II · 2017Depuy Fracture and Fusion Plating System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HRS Plate, Fixation, Bone
Cleared on Feb 2, 2010 after an 88-day review. The FDA summary names no predicate by number. 16 later devices descend from it. It has been recalled 2 times.
- Decided
- Feb 2, 2010
- Review
- 88 days
- Class
- Class II
- Product code
- HRS
- Recalls
- 2
- Predicates
- 0
16 later devices descend from it, 4 citing it directly.
- This deviceK093474 Depuy Fracture and Fusion Plating SystemDePuy Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 11 of its ownK132898 A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013
- Descendant · 2 generations on · 6 of its ownK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- Descendant · 3 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 2 generations on · 1 of its ownK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
- Descendant · 3 generations on · 1 of its ownK190391 TDM Plate and Screw SystemsTdm Co., Ltd. · 2019
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013 · cites it directly11descendants
- K171808TDM Plate and Screw SystemTdm Co., Ltd. · 2018 · 2 generations on6descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 3 generations on2descendants
- K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023 · 2 generations on1descendant
- K190391TDM Plate and Screw SystemsTdm Co., Ltd. · 2019 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093474 | Depuy Fracture and Fusion Plating System | DePuy Orthopaedics, Inc. | 2010 | — |
| +1 | K132898 | A.L.P.S. Calcaneal Plating System | Biomet Manufacturing Corp | 2013 | — |
| +2 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| +3 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +2 | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
| +3 | K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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?
The FDA summary names no predicate by number.
What descends from it? (16)
See all 164 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2017 | Class II | Z-1306-2018 | Unknown/Undetermined by firm | The drill guides were manufactured with the incorrect color anodization. |
| Jun 4, 2015 | Class II | Z-2046-2015 | Process change control | The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K132898 (Biomet Manufacturing Corp, 2013) has gone furthest, with 11 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. 2010, 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 DePuy Fracture and Fusion Plating System is intended for use in stabilization and fixation of fractures, revision procedures, fusions, reconstructions (osteotomy) and non-unions of the bones of the hand, foot, wrist, ankle, finger, toe, humerus, olecranon, clavicle, scapula and pelvis, particularly in osteopenic bone. The system can be used in both adult and pediatric patients (adolescents [>12 - 21 years of age]), where the implant would not cross open epiphyseal plates in skeletally immature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093474 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093474: Depuy Fracture and Fusion Plating System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093474
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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