510(k) · Cleared
Recalled · Class II · 2019Trilliant Surgical K-Wires
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trilliant Surgical, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Jun 4, 2012 as substantially equivalent to K030336 (Teleflex Medical Group, 2003) after a 62-day review. Its family tree reaches back 3 generations to 1996. 7 later devices descend from it. It has been recalled once.
- Decided
- Jun 4, 2012
- Review
- 62 days
- Class
- Class II
- Product code
- HTY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K960385 (1996). 4 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 2 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 1 generation backK030336 Kmedic External Fixation DevicesTeleflex Medical Group · 2003
- This deviceK121008 Trilliant Surgical K-WiresTrilliant Surgical, Ltd. · 2012
- Descendant · cites it directly · 5 of its ownK161449 HammerTech Fixation SystemFusion Orthopedics, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 3 generations on · 2 of its ownK213421 Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · 4 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K161449HammerTech Fixation SystemFusion Orthopedics, LLC · 2016 · cites it directly5descendants
- K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on3descendants
- K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · 3 generations on2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 4 generations on1descendant
- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −2 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −1 | K030336 | Kmedic External Fixation Devices | Teleflex Medical Group | 2003 | — |
| 0 (this device) | K121008 | Trilliant Surgical K-Wires | Trilliant Surgical, Ltd. | 2012 | — |
| +1 | K161449 | HammerTech Fixation System | Fusion Orthopedics, LLC | 2016 | — |
| +2 | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +3 | K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +4 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +5 | K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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 |
|---|---|---|---|
| * | K030336 | Kmedic External Fixation DevicesSummary page 1…n: 21 CFR section 888.3040 Device panel: Orthopedic Legally Marketed Predicate Device: K-Medic External Fixation Devices - (K030336 - Teleflex Medical Group) Submitter: Trilliant Surgical LTD 602 Sawyer Stree… | 2003 |
What descends from it? (7)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2019 | Class II | Z-1635-2020 | Mixed-up of materials/components | The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K161449 (Fusion Orthopedics, LLC, 2016) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K030336.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Trilliant Surgical K-wires are intended for use in fixation of bone fractures, for bone reconstructions, and as guide pins for insertion of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121008 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121008: Trilliant Surgical K-Wires.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121008
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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