510(k) · Cleared
ClearedArthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTY Pin, Fixation, Smooth
Cleared on Nov 3, 2005 after a 34-day review. The FDA summary names no predicate by number. 14 later devices descend from it.
- Decided
- Nov 3, 2005
- Review
- 34 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 4 citing it directly.
- This deviceK052736 Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XTArthrex, Inc. · 2005
- Descendant · cites it directly · 10 of its ownK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- Descendant · cites it directly · 9 of its ownK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
- Descendant · 2 generations on · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
- Descendant · 3 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
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K100926Arrowhead Fixation DeviceArrow Products, Inc. · 2010 · cites it directly10descendants
- K112675Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · cites it directly9descendants
- K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · 2 generations on4descendants
- K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 3 generations on3descendants
- K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K052736 | Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT | Arthrex, Inc. | 2005 | — |
| +1 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| +1 | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | 1 |
| +2 | K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019 | — |
| +3 | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +3 | K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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?
The FDA summary names no predicate by number.
What descends from it? (14)
See all 144 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, K100926 (Arrow Products, Inc., 2010) has gone furthest, with 10 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 | — |
What is it indicated for?
The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.
Examples include:
Fixation of small bone fragments, in long bone or small bone fractures
Arthrodesis in hand and foot surgery
Distal or proximal metatarsal or metacarpal osteotomies
Mono or Bi-Cortical osteotomies in the foot or hand
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc)
Guide Wire in hip pinning procedures
Align and reduce long bone fractures
For use with cerclage wire/cable in treating greater trochanter fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052736: Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052736
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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