510(k) · Cleared
ClearedHyProCure II
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graham Medical Technologies, LLC Dba Gramedica · HWC Screw, Fixation, Bone
Cleared on Oct 3, 2014 as substantially equivalent to K042030 (Graham Medical Technologies, LLC, 2004) after a 24-day review. Its family tree reaches back 1 generation to 2004. 2 later devices descend from it.
- Decided
- Oct 3, 2014
- Review
- 24 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042030 (2004). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK042030 Hyprocure Subtalar Implant SystemGraham Medical Technologies, LLC · 2004
- This deviceK142534 HyProCure IIGraham Medical Technologies, LLC Dba Gramedica · 2014
- Descendant · cites it directly · 0 of its ownK251382 Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK170624 TalarLift STSFusion Orthopedics, LLC · 2017
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 | K042030 | Hyprocure Subtalar Implant System | Graham Medical Technologies, LLC | 2004 | — |
| 0 (this device) | K142534 | HyProCure II | Graham Medical Technologies, LLC Dba Gramedica | 2014 | — |
| +1 | K251382 | Phoenix Sinus Tarsi Stent System | Astra Orthomed, Inc. | 2025 | — |
| +1 | K170624 | TalarLift STS | Fusion Orthopedics, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 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 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? (1)
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 |
|---|---|---|---|
| * | K042030 | Hyprocure Subtalar Implant SystemSummary page 4…e HyProCure II (HYP II and HYP IIs) Common Name Sinus Tarsi Implant Code –Classification HWC 21 CFR 888.3040 : Class II Predicate Devices K042030 HyProCure Subtalar Implant System Device Description The HyProCure II is an implant which stabilizes the talus on the ta… | 2004 |
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 HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142534 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142534: HyProCure II.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142534
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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