510(k) · Cleared
ClearedCalcamea Plate
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
New Deal, S.A. · HRS Plate, Fixation, Bone
Cleared on Sep 8, 2004 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 3 other predicates after a 69-day review. Its family tree reaches back 2 generations to 1992. 13 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K915818 (1992). 6 ancestors in all. 13 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 1 generation backK981775 Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998
- This deviceK041786 Calcamea PlateNew Deal, S.A. · 2004
- Descendant · cites it directly · 12 of its ownK090582 Calcaneal Fracture Plate SystemTornier, Inc. · 2009
- Descendant · 2 generations on · 11 of its ownK132898 A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013
- Descendant · 3 generations on · 6 of its ownK171808 TDM Plate and Screw SystemTdm Co., Ltd. · 2018
- Descendant · 4 generations on · 2 of its ownK242939 ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024
- Descendant · 3 generations on · 1 of its ownK221150 Advanced Bone PlateDouble Medical Technology, Inc. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K090582Calcaneal Fracture Plate SystemTornier, Inc. · 2009 · cites it directly12descendants
- K132898A.L.P.S. Calcaneal Plating SystemBiomet Manufacturing Corp · 2013 · 2 generations on11descendants
- K171808TDM Plate and Screw SystemTdm Co., Ltd. · 2018 · 3 generations on6descendants
- K242939ARTFX Trauma Bone Plate and Screw SystemArtfx Medical · 2024 · 4 generations on2descendants
- K221150Advanced Bone PlateDouble Medical Technology, Inc. · 2023 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −1 | K981775 | Depuy Ace Timax Calcaneal Peri-Articular Plate | Depuy Ace Medical Co. | 1998 | — |
| 0 (this device) | K041786 | Calcamea Plate | New Deal, S.A. | 2004 | — |
| +1 | K090582 | Calcaneal Fracture Plate System | Tornier, Inc. | 2009 | — |
| +2 | K132898 | A.L.P.S. Calcaneal Plating System | Biomet Manufacturing Corp | 2013 | — |
| +3 | K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018 | — |
| +4 | K242939 | ARTFX Trauma Bone Plate and Screw System | Artfx Medical | 2024 | — |
| +3 | K221150 | Advanced Bone Plate | Double Medical Technology, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 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? (4)
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 |
|---|---|---|---|
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 2…A T-PLATE is similar in design and function to the predicates SYNTHES Locking Calcaneal Plates (K991407 - K020401) and the DEPUY ACE Calcaneal Peri-Articular Plate (K993465 - K981775).… | 1999 |
| * | K020401 | Synthes Calcaneal PlateSummary page 2…is similar in design and function to the predicates SYNTHES Locking Calcaneal Plates (K991407 - K020401) and the DEPUY ACE Calcaneal Peri-Articular Plate (K993465 - K981775).… | 2002 |
| * | K993465 | Depuy Ace Calcaneal Peri-Articular PlateSummary page 2…Locking Calcaneal Plates (K991407 - K020401) and the DEPUY ACE Calcaneal Peri-Articular Plate (K993465 - K981775). Based on the information provided in this premarket… | 2000 |
| * | K981775 | Depuy Ace Timax Calcaneal Peri-Articular PlateSummary page 2…alcaneal Plates (K991407 - K020401) and the DEPUY ACE Calcaneal Peri-Articular Plate (K993465 - K981775). Based on the information provided in this premarket n… | 1998 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090582 | Calcaneal Fracture Plate System | 2009 | 12 |
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 12 years and passes through 3 companies; a new generation was cleared every 6.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K090582 (Tornier, Inc., 2009) has gone furthest, with 12 descendants of its own.
- 15 other devices also cite its predicate K991407.
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 CALCANEA TM -PLATE is indicated for use in fixation of fractures or osteotomies of the calcaneus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041786 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041786: Calcamea Plate.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041786
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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