510(k) · Cleared
ClearedFixation Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Simpex, Inc. · HTY Pin, Fixation, Smooth
Cleared on Apr 12, 1991 after an 8-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.
- Decided
- Apr 12, 1991
- Review
- 8 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK911505 Fixation WireSimpex, Inc. · 1991
- Descendant · cites it directly · 9 of its ownK112727 Medical Facets Corical Screws, Medical Facets Cancellous Screws…Medical Facets · 2012
- Descendant · 2 generations on · 5 of its ownK132820 Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014
- Descendant · 3 generations on · 4 of its ownK163487 Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017
- Descendant · 4 generations on · 1 of its ownK243798 Orthex External Fixation SystemOrthoPediatrics Corp. · 2025
- Descendant · 3 generations on · 1 of its ownK202054 Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K112727Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless…Medical Facets · 2012 · cites it directly9descendants
- K132820Vilex Ultima External Fixation System with HA Coated Pins and WiresVilex, Inc. · 2014 · 2 generations on5descendants
- K163487Ultima HA Coated Half Pins and WireVilex IN Tennessee, Inc. · 2017 · 3 generations on4descendants
- K243798Orthex External Fixation SystemOrthoPediatrics Corp. · 2025 · 4 generations on1descendant
- K202054Dynex Ring Fixation System, Diametrix Ring Fixation SystemVilex, LLC · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K911505 | Fixation Wire | Simpex, Inc. | 1991 | — |
| +1 | K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical… | Medical Facets | 2012 | — |
| +2 | K132820 | Vilex Ultima External Fixation System with HA Coated Pins and Wires | Vilex, Inc. | 2014 | — |
| +3 | K163487 | Ultima HA Coated Half Pins and Wire | Vilex IN Tennessee, Inc. | 2017 | — |
| +4 | K243798 | Orthex External Fixation System | OrthoPediatrics Corp. | 2025 | — |
| +3 | K202054 | Dynex Ring Fixation System, Diametrix Ring Fixation System | Vilex, LLC | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112727 | Medical Facets Corical Screws, Medical Facets Cancellous Screws, Medical Facets Headless… | 2012 | 9 |
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, K112727 (Medical Facets, 2012) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K911505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K911505: Fixation Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K911505
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026