510(k) · Cleared
ClearedSnapHammer 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 Feb 16, 2024 as substantially equivalent to K221283 (4Web Medical, Inc., 2022) and 1 other predicate after a 274-day review. Its family tree reaches back 12 generations to 1979. 1 later device descends from it.
- Decided
- Feb 16, 2024
- Review
- 274 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K792022 (1979). 98 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations between
- 3 generations backK160264 Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016
- 2 generations backK190926 Hammertoe Truss System (HTS)4Web, Inc. · 2019
- 1 generation backK221283 Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022
- This deviceK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
Show all 12 generations
- Root · 12 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 11 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 10 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 9 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 8 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 7 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 6 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 5 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 4 generations backK141420 FastforwardMedShape, Inc. · 2014
- 3 generations backK160264 Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016
- 2 generations backK190926 Hammertoe Truss System (HTS)4Web, Inc. · 2019
- 1 generation backK221283 Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022
- This deviceK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −11 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −10 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −9 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −8 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −7 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −6 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −5 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −4 | K141420 | Fastforward | MedShape, Inc. | 2014 | — |
| −3 | K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016 | — |
| −2 | K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019 | — |
| −1 | K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022 | — |
| 0 (this device) | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +1 | 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 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 5 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 22.2 · 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? (2)
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 |
|---|---|---|---|
| * | K221283 | Hammertoe Truss System (HTS)Summary page 5…orrection System is substantially equivalent to the following predicates: 510(k) Number Predicate Device Name / Manufacturer Predicate K221283 4Webb Medical Inc. Hammertoe Truss System (HTS)* Primary K213421 Nvision Vector Hammertoe Co… | 2022 |
| * | K213421 | Vector® Hammertoe Correction SystemSummary page 5…Predicate Device Name / Manufacturer Predicate K221283 4Webb Medical Inc. Hammertoe Truss System (HTS)* Primary K213421 Nvision Vector Hammertoe Correction System** Additional *Additional clearances include K190926… | 2021 |
| † | K210424 | Quantum Anterior Cervical Plate | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250613 | SnapHammer Hammertoe Correction System | 2025 | 0 |
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 45 years and passes through 10 companies; a new generation was cleared every 1.8 years on median.
- 9 of the 98 ancestors have a recall of any class.
- Of its descendants, K250613 (Nvision Biomedical Technologies, Inc., 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SnapHammer 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. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231453 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231453: SnapHammer Hammertoe Correction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231453
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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