510(k) · Cleared
ClearedVector Hammertoe Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nvision Biomedical Technologies, Inc. · HWC Screw, Fixation, Bone
Cleared on Aug 4, 2020 as substantially equivalent to K183055 (Nvision Biomedical Technologies, LLC, 2019) and 2 other predicates after a 29-day review. Its family tree reaches back 7 generations to 1998. 3 later devices descend from it.
- Decided
- Aug 4, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K983121 (1998). 42 ancestors in all, the oldest K792670 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
- 6 generations backK993910 Tac' PinNew Deal, S.A. · 2000
- 5 generations backK051740 Tapered Compression PinNexa Orthopedics, Inc. · 2005
- 4 generations backK072710 Nexfix Compression PinNexa Orthopedics, Inc. · 2007
- 3 generations backK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- 2 generations backK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
- 1 generation backK183055 Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC · 2019
- This deviceK201850 Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK213421 Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021
- Descendant · 2 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K213421Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2021 · cites it directly2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 2 generations on1descendant
- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| −6 | K993910 | Tac' Pin | New Deal, S.A. | 2000 | — |
| −5 | K051740 | Tapered Compression Pin | Nexa Orthopedics, Inc. | 2005 | — |
| −4 | K072710 | Nexfix Compression Pin | Nexa Orthopedics, Inc. | 2007 | — |
| −3 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| −2 | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | 1 |
| −1 | K183055 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, LLC | 2019 | — |
| 0 (this device) | K201850 | Vector Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +1 | K213421 | Vector® Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2021 | — |
| +2 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +3 | K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 4 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.3 · 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 |
|---|---|---|---|
| * | K183055 | Vector Hammertoe Correction SystemSummary page 5…Predicate Device Name / Manufacturer Primary Predicate K183055 VECTOR™ Hammertoe Correction System 9 K161449 Fusion Orthopedics HammerTech F… | 2019 |
| * | K161449 | HammerTech Fixation SystemSummary page 5…Predicate K183055 VECTOR™ Hammertoe Correction System 9 K161449 Fusion Orthopedics HammerTech Fixation System K133636 Extremity Medical HammerFIX Device SUMMARY OF NON-CLINI… | 2016 |
| * | K133636 | Extremity Medical Hammertoe DeviceSummary page 5…ate K183055 VECTOR™ Hammertoe Correction System 9 K161449 Fusion Orthopedics HammerTech Fixation System K133636 Extremity Medical HammerFIX Device SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for… | 2014 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213421 | Vector® Hammertoe Correction System | 2021 | 2 |
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 22 years and passes through 7 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 42 ancestors have a recall of any class.
- Of its descendants, K213421 (Nvision Biomedical Technologies, Inc., 2021) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K183055.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201850 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201850: Vector Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201850
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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