510(k) · Cleared
ClearedDePuy Synthes 3.5mm Intrapelvic Acetabular System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Synthes · HRS Plate, Fixation, Bone
Cleared on Sep 20, 2022 as substantially equivalent to K042377 (Synthes (Usa), 2004) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- Sep 20, 2022
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K031573 (2003). 2 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK031573 Synthes 3.5 MM Low Profile Pelvic Reconstruction PlateSynthes (Usa) · 2003
- This deviceK221809 DePuy Synthes 3.5mm Intrapelvic Acetabular SystemDePuy Synthes · 2022
- Descendant · cites it directly · 0 of its ownK260054 I.T.S. PRS Phoenix III.T.S. GmbH · 2026
- Descendant · cites it directly · 0 of its ownK241666 EVOS Pelvic and Acetabular SystemSmith & Nephew · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K031573 | Synthes 3.5 MM Low Profile Pelvic Reconstruction Plate | Synthes (Usa) | 2003 | — |
| 0 (this device) | K221809 | DePuy Synthes 3.5mm Intrapelvic Acetabular System | DePuy Synthes | 2022 | — |
| +1 | K260054 | I.T.S. PRS Phoenix II | I.T.S. GmbH | 2026 | — |
| +1 | K241666 | EVOS Pelvic and Acetabular System | Smith & Nephew | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K042377 | Synthes Low Profile Reconstruction PlatesSummary page 4…Product Code: HRS Primary Predicate: Synthes (USA) Low Profile Reconstruction Plates K042377 • 3.5 mm Wide Angle Low Profile Reconstruction Plates • 3.5 mm Low Profile Re… | 2004 |
| * | K031573 | Synthes 3.5 MM Low Profile Pelvic Reconstruction PlateSummary page 4…ocking) Predicate devices Additional Predicate: Synthes 3.5 mm Low Profile Pelvic Reconstruction Plate K031573 • 3.5 mm Low Profile Reconstruction Plates • 3.5 mm Low Profile Curved Recons… | 2003 |
What descends from it? (2)
2 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?
How does its category compare?
All HRS devicesHRS Plate, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Synthes 3.5 mm Intrapelvic Acetabular Plates are indicated for fractures of the acetabulum in adults and adolescents (greather than 12 through 21 years of age) where all growth plates within the acetabulum are fused.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221809 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221809: DePuy Synthes 3.5mm Intrapelvic Acetabular System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221809
Report an extraction error
Are you the manufacturer?
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