510(k) · Cleared
ClearedDepuy Ace Calcaneal Peri-Articular Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · HRS Plate, Fixation, Bone
Cleared on Jan 11, 2000 as substantially equivalent to K915818 (Synthes (Usa), 1992) after a 90-day review. Its family tree reaches back 1 generation to 1992. 42 later devices descend from it.
- Decided
- Jan 11, 2000
- Review
- 90 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915818 (1992). 42 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- This deviceK993465 Depuy Ace Calcaneal Peri-Articular PlateDepuy, Inc. · 2000
- Descendant · cites it directly · 28 of its ownK051642 FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2005 · Recalled
- Descendant · 2 generations on · 27 of its ownK060156 Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · Recalled
- Descendant · cites it directly · 13 of its ownK041786 Calcamea PlateNew Deal, S.A. · 2004
- Descendant · 2 generations on · 12 of its ownK090582 Calcaneal Fracture Plate SystemTornier, Inc. · 2009
- Descendant · 3 generations on · 11 of its ownK132898 A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K051642FR.O.H. Calcaneus Repair SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2005 · cites it directly28descendants
- K060156Straight Plate with Angular Stability & Screw SystemI.T.S. Implantat-Technologie-Systeme GmbH · 2006 · 2 generations on27descendants
- K041786Calcamea PlateNew Deal, S.A. · 2004 · cites it directly13descendants
- K090582Calcaneal Fracture Plate SystemTornier, Inc. · 2009 · 2 generations on12descendants
- K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| 0 (this device) | K993465 | Depuy Ace Calcaneal Peri-Articular Plate | Depuy, Inc. | 2000 | — |
| +1 | K051642 | FR.O.H. Calcaneus Repair System | I.T.S. Implantat-Technologie-Systeme GmbH | 2005 | 1 |
| +2 | K060156 | Straight Plate with Angular Stability & Screw System | I.T.S. Implantat-Technologie-Systeme GmbH | 2006 | 2 |
| +1 | K041786 | Calcamea Plate | New Deal, S.A. | 2004 | — |
| +2 | K090582 | Calcaneal Fracture Plate System | Tornier, Inc. | 2009 | — |
| +3 | K132898 | A.L.P.S. Calcaneal Plating System | Biomet Manufacturing Corp | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K915818 | Synthes (R) Titanium Small Reconstruction PlateSummary page 2…e same and the design is essentially the same. The subject DePuy ACE calcaneal plates are similar in design and function to the predicate Synthes Calcaneal Plate (510(k) K915818). Based on the information provided in this premarket notification, DePuy considers the subject devices to be substantially equiv… | 1992 |
| * | — | DePuy ACE Calcaneal Plates Named without a submission number |
What descends from it? (42)
See all 423 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.
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 ACE Calcaneal Peri-Articular Plates are designed to assist the surgeon in the management of:
Intra-articular fractures of the calcaneus
Extra-articular fractures of the calcaneus
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/K993465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993465: Depuy Ace Calcaneal Peri-Articular Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993465
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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