510(k) · Cleared
ClearedCalcaneal Fracture Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tornier, Inc. · HRS Plate, Fixation, Bone
Cleared on Jul 2, 2009 as substantially equivalent to K991407 (Synthes (Usa), 1999) and 1 other predicate after a 120-day review. Its family tree reaches back 3 generations to 1992. 12 later devices descend from it.
- Decided
- Jul 2, 2009
- Review
- 120 days
- Class
- Class II
- Product code
- HRS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K915818 (1992). 7 ancestors in all. 12 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK915818 Synthes (R) Titanium Small Reconstruction PlateSynthes (Usa) · 1992 · Recalled
- 2 generations backK981775 Depuy Ace Timax Calcaneal Peri-Articular PlateDepuy Ace Medical Co. · 1998
- 1 generation backK041786 Calcamea PlateNew Deal, S.A. · 2004
- This deviceK090582 Calcaneal Fracture Plate SystemTornier, Inc. · 2009
- 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 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · 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 |
|---|---|---|---|---|---|
| −3 | K915818 | Synthes (R) Titanium Small Reconstruction Plate | Synthes (Usa) | 1992 | 2 |
| −2 | K981775 | Depuy Ace Timax Calcaneal Peri-Articular Plate | Depuy Ace Medical Co. | 1998 | — |
| −1 | K041786 | Calcamea Plate | New Deal, S.A. | 2004 | — |
| 0 (this device) | K090582 | Calcaneal Fracture Plate System | Tornier, Inc. | 2009 | — |
| +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 | — |
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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K991407 | Synthes Locking Calcaneal PlatesSummary page 2…STM F138.. Conclusion: The Tornier Caleaneal. Fracture Plate System is substantially equivalent to commercially marketed devices, the Synthes Locking Calcaneal Plates,' K991407 and the Newdeal Calcanea-m Plate, K041 786 The Tornier Calcaneal Fracture Plate System does not raise-any new issues of scientifi… | 1999 |
| * | K041786 | Calcamea PlateSummary page 2…ures. Comparison of Technological Characteristics: The Tornier Calcaneal .Fracture'Plate System, Synthes Locking Calcaneal Plates, and the Newdeal Calcanea rM ' Plate, K041786 have equivalent Intended Use and are indicated for. fixation of fractures and. osteotomies of the calcaneus Like the predicate; t… | 2004 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132898 | A.L.P.S. Calcaneal Plating System | 2013 | 11 |
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 17 years and passes through 4 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K132898 (Biomet Manufacturing Corp, 2013) has gone furthest, with 11 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. 2009, 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 Tornier Calcaneal Fracture Plate System is indicated for fractures and osteotomies of the calcaneus, including, but not limited to extra-articular, intra-articular, joint depression, tongue-type and severely comminuted fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090582: Calcaneal Fracture Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090582
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