510(k) · Cleared
ClearedSynthes 3.5MM Quadrilateral Surface 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 Mar 29, 2010 after a 97-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Mar 29, 2010
- Review
- 97 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK093928 Synthes 3.5MM Quadrilateral Surface PlatesSynthes (Usa) · 2010
- Descendant · cites it directly · 3 of its ownK210935 I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · Recalled
- Descendant · 2 generations on · 0 of its ownK260958 I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius…I.T.S. GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 2026
- Descendant · 2 generations on · 0 of its ownK241666 EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
- Descendant · cites it directly · 0 of its ownK201229 Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation · 2022
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K210935I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix)I.T.S. GmbH · 2022 · cites it directly3descendants
- K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular…I.T.S. GmbH · 2026 · 2 generations on0descendants
- K260054I.T.S. PRS Phoenix III.T.S. GmbH · 2026 · 2 generations on0descendants
- K241666EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025 · 2 generations on0descendants
- K201229Intai Anatomic Locking Plate and Screw SystemIntai Technology Corporation · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K093928 | Synthes 3.5MM Quadrilateral Surface Plates | Synthes (Usa) | 2010 | — |
| +1 | K210935 | I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) | I.T.S. GmbH | 2022 | 1 |
| +2 | K260958 | I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with… | I.T.S. GmbH | 2026 | — |
| +2 | K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026 | — |
| +2 | K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew | 2025 | — |
| +1 | K201229 | Intai Anatomic Locking Plate and Screw System | Intai Technology Corporation | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2022 | 2 | 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? (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 Plates Named without a submission number |
What descends from it? (6)
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, K210935 (I.T.S. GmbH, 2022) has gone furthest, with 3 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?
Synthes 3.5mm Quadrilateral Surface Plates are indicated for quadrilateral surface comminution associated with acetabular fractures when used in conjunction with Synthes pelvic reconstruction plates.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093928 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093928: Synthes 3.5MM Quadrilateral Surface Plates.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093928
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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