510(k) · Cleared
ClearedArrowhead Fixation Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrow Products, Inc. · HTY Pin, Fixation, Smooth
Cleared on Oct 29, 2010 as substantially equivalent to K022599 (New Deal, S.A., 2002) and 5 other predicates after a 207-day review. Its family tree reaches back 4 generations to 1998. 10 later devices descend from it.
- Decided
- Oct 29, 2010
- Review
- 207 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 4 generations to K983121 (1998). 12 ancestors in all, the oldest K960385 (1996). 10 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
- 3 generations backK993910 Tac' PinNew Deal, S.A. · 2000
- 2 generations backK051740 Tapered Compression PinNexa Orthopedics, Inc. · 2005
- 1 generation backK072710 Nexfix Compression PinNexa Orthopedics, Inc. · 2007
- This deviceK100926 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
- Descendant · 2 generations on · 2 of its ownK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- 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
- K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| −3 | K993910 | Tac' Pin | New Deal, S.A. | 2000 | — |
| −2 | K051740 | Tapered Compression Pin | Nexa Orthopedics, Inc. | 2005 | — |
| −1 | K072710 | Nexfix Compression Pin | Nexa Orthopedics, Inc. | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | In2bones Sas | 2014 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K022599 | Newdeal K WireSummary page 1…truction in the lesser toes following corrective procedures. It is not intended for use in the spine. newdeal, S.A. K-wire (K022599) Arthrex, Inc. K-wire (K052736) Nexa Orthopedics, Inc. Nexfix Compression Pin (K0727… | 2002 |
| * | K052736 | Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XTSummary page 1…edures. It is not intended for use in the spine. newdeal, S.A. K-wire (K022599) Arthrex, Inc. K-wire (K052736) Nexa Orthopedics, Inc. Nexfix Compression Pin (K0727 10) Predicate Devices BioPro Inc., DCS (K963433)… | 2005 |
| * | K072710 | Nexfix Compression PinSummary page 1…newdeal, S.A. K-wire (K022599) Arthrex, Inc. K-wire (K052736) Nexa Orthopedics, Inc. Nexfix Compression Pin (K0727 10) Predicate Devices BioPro Inc., DCS (K963433) Wright Medical Technologies, Inc. PRO-TOE VO Hammertoe (K… | 2007 |
| * | K963433 | Threaded Fixation PinSummary page 1…Arthrex, Inc. K-wire (K052736) Nexa Orthopedics, Inc. Nexfix Compression Pin (K0727 10) Predicate Devices BioPro Inc., DCS (K963433) Wright Medical Technologies, Inc. PRO-TOE VO Hammertoe (KlOI 165) Merete Medical GMB… | 1996 |
| * | K101165 | Pro-Toe VO Hammertow Implant System Cleared while this submission was under review | 2010 |
| * | K100414 | Protoe Endosorb Small Hammer Toe Pin Cleared while this submission was under review Summary page 1…ht Medical Technologies, Inc. PRO-TOE VO Hammertoe (KlOI 165) Merete Medical GMBH PRO TOE Endosorb Small Hammer Toe Pin (K 1004 14) Page 1 of 2 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS… | 2010 |
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 |
|---|---|---|---|
| K112675 | Arrow-Lok Digital System | 2011 | 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?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K112675 (Arrowhead Medical Device Technologies, LLC, 2011) has gone furthest, with 9 descendants of its own.
- 22 other devices also cite its predicate K022599.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Arrowhead is indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures. It is not intended for use in the spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100926 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100926: Arrowhead Fixation Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100926
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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