510(k) · Cleared
ClearedHyprocure Subtalar Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graham Medical Technologies, LLC · HWC Screw, Fixation, Bone
Cleared on Sep 16, 2004 after a 50-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 10 later devices descend from it.
- Decided
- Sep 16, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 5 citing it directly.
- This deviceK042030 Hyprocure Subtalar Implant SystemGraham Medical Technologies, LLC · 2004
- Descendant · cites it directly · 4 of its ownK103183 Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · 2 generations on · 3 of its ownK111834 Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · Recalled
- Descendant · cites it directly · 2 of its ownK142534 HyProCure IIGraham Medical Technologies, LLC Dba Gramedica · 2014
- Descendant · 3 generations on · 2 of its ownK133035 Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013
- Descendant · cites it directly · 0 of its ownK251382 Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K103183Trilliant Surgical Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · cites it directly4descendants
- K111834Disco Subtalar ImplantTrilliant Surgical, Ltd. · 2011 · 2 generations on3descendants
- K142534HyProCure IIGraham Medical Technologies, LLC Dba Gramedica · 2014 · cites it directly2descendants
- K133035Normed Pellegrin Calcaneus Stop ScrewNormed Medizin-Technik GmbH · 2013 · 3 generations on2descendants
- K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042030 | Hyprocure Subtalar Implant System | Graham Medical Technologies, LLC | 2004 | — |
| +1 | K103183 | Trilliant Surgical Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +2 | K111834 | Disco Subtalar Implant | Trilliant Surgical, Ltd. | 2011 | 1 |
| +1 | K142534 | HyProCure II | Graham Medical Technologies, LLC Dba Gramedica | 2014 | — |
| +3 | K133035 | Normed Pellegrin Calcaneus Stop Screw | Normed Medizin-Technik GmbH | 2013 | — |
| +1 | K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (10)
5 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, K103183 (Trilliant Surgical, Ltd., 2011) has gone furthest, with 4 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The HyProCure Subtalar Implant is indicated for use in the treatment of the hyperpronated foot by stabilization of the subtalar joint. The implant is designed to block anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042030: Hyprocure Subtalar Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042030
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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