510(k) · Cleared
Recalled · Class II · 2026Arrow-Lok Digital System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arrowhead Medical Device Technologies, LLC · HTY Pin, Fixation, Smooth
Cleared on Dec 12, 2011 as substantially equivalent to K100926 (Arrow Products, Inc., 2010) and 2 other predicates after an 89-day review. Its family tree reaches back 5 generations to 1998. 9 later devices descend from it. It has been recalled once.
- Decided
- Dec 12, 2011
- Review
- 89 days
- Class
- Class II
- Product code
- HTY
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 5 generations to K983121 (1998). 13 ancestors in all, the oldest K960385 (1996). 9 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
- 4 generations backK993910 Tac' PinNew Deal, S.A. · 2000
- 3 generations backK051740 Tapered Compression PinNexa Orthopedics, Inc. · 2005
- 2 generations backK072710 Nexfix Compression PinNexa Orthopedics, Inc. · 2007
- 1 generation backK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- This deviceK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011
- Descendant · cites it directly · 4 of its ownK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK213421 Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · cites it directly · 2 of its ownK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K183055Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019 · cites it directly4descendants
- K201850Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on3descendants
- K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · 2 generations on2descendants
- K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · cites it directly2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| −4 | K993910 | Tac' Pin | New Deal, S.A. | 2000 | — |
| −3 | K051740 | Tapered Compression Pin | Nexa Orthopedics, Inc. | 2005 | — |
| −2 | K072710 | Nexfix Compression Pin | Nexa Orthopedics, Inc. | 2007 | — |
| −1 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| 0 (this device) | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | — |
| +1 | K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019 | — |
| +2 | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +2 | K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +1 | K132912 | Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant | In2bones Sas | 2014 | 2 |
| +3 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
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 |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K100926 | Arrowhead Fixation DeviceSummary page 1…toes Intended Use following corrective procedures. It is not intended for use in the spine. Arrowhead Fixation Device (K100926) Predicate Devices NEWDEAL, S.A. K-wire (K022599) Arthrex, Inc. K-wire (K052736)… | 2010 |
| * | K022599 | Newdeal K WireSummary page 1…dures. It is not intended for use in the spine. Arrowhead Fixation Device (K100926) Predicate Devices NEWDEAL, S.A. K-wire (K022599) Arthrex, Inc. K-wire (K052736) rMl~kl… | 2002 |
| * | K052736 | Arthrex K-Wire ,Threaded Models AR-8990 to 899X, AR-8991T to AR-899XTSummary page 1…spine. Arrowhead Fixation Device (K100926) Predicate Devices NEWDEAL, S.A. K-wire (K022599) Arthrex, Inc. K-wire (K052736) rMl~kl'S (pI 2/z7) Exhi… | 2005 |
What descends from it? (9)
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 |
|---|---|---|---|---|
| Jun 23, 2026 | Class II | Z-2958-2026 | Process change control | Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures, did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 5 companies; a new generation was cleared every 2.2 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K183055 (Nvision Biomedical Technologies, LLC, 2019) has gone furthest, with 4 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. 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 ARROW-LOK implant is indicated for fixation of osteotomnies, 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/K112675 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112675: Arrow-Lok Digital System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112675
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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