510(k) · Cleared
ClearedVerticor K-Wire System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Verticor, Ltd. · HTY Pin, Fixation, Smooth
Cleared on Feb 28, 2011 as substantially equivalent to K030336 (Teleflex Medical Group, 2003) and 1 other predicate after a 53-day review. Its family tree reaches back 3 generations to 1996.
- Decided
- Feb 28, 2011
- Review
- 53 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K960385 (1996). 8 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK110047 Verticor K-Wire SystemVerticor, Ltd. · 2011
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) | K110047 | Verticor K-Wire System | Verticor, Ltd. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 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? (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 |
|---|---|---|---|
| * | K030336 | Kmedic External Fixation DevicesSummary page 1…Class 11 3. Predicate or legally marketed devices which are substantially equivalent: KMedic External Fixation Devices (K030336 - Teleflex Medical Group) SMVT Schilling Kirschner/Guide Wires (K100736 - SMVT Schilling Metailtechnik GmbH) 4. Descr… | 2003 |
| * | K100736 | Kirschner and Guide WiresSummary page 1…d devices which are substantially equivalent: KMedic External Fixation Devices (K030336 - Teleflex Medical Group) SMVT Schilling Kirschner/Guide Wires (K100736 - SMVT Schilling Metailtechnik GmbH) 4. Description of the device: K-wires are sharpened or blunt, smooth stainless st… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 8 ancestors has a recall.
- 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. 2011, 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 Verticor K-Wire System is intended for use in fixation of bone fractures, fusion of joints or bone reconstruction, for osteotomies in the presence of adequate immobilization and as guide pins for insertion of other implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110047 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110047: Verticor K-Wire System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110047
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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