510(k) · Cleared
ClearedAdditive Orthopaedics Hammertoe Correction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Orthopaedics, LLC · HTY Pin, Fixation, Smooth
Cleared on Jun 1, 2016 as substantially equivalent to K050259 (Arthrex, Inc., 2005) and 2 other predicates after a 120-day review. Its family tree reaches back 9 generations to 1979. 4 later devices descend from it.
- Decided
- Jun 1, 2016
- Review
- 120 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K792022 (1979). 50 ancestors in all. 4 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations between
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 1 generation backK141420 FastforwardMedShape, Inc. · 2014
- This deviceK160264 Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016
- Descendant · cites it directly · 3 of its ownK190926 Hammertoe Truss System (HTS)4Web, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK221283 Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK231453 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024
- Descendant · 4 generations on · 0 of its ownK250613 SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025
Show all 9 generations
- Root · 9 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 8 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 7 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 6 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 5 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 4 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 3 generations backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 2 generations backK061925 Mini Tightrope Repair Kit, Model AR-8911DSArthrex, Inc. · 2006
- 1 generation backK141420 FastforwardMedShape, Inc. · 2014
- This deviceK160264 Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K190926Hammertoe Truss System (HTS)4Web, Inc. · 2019 · cites it directly3descendants
- K221283Hammertoe Truss System (HTS)4Web Medical, Inc. · 2022 · 2 generations on2descendants
- K231453SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2024 · 3 generations on1descendant
- K250613SnapHammer Hammertoe Correction SystemNvision Biomedical Technologies, Inc. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −8 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −7 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −6 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −5 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −4 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| −3 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| −2 | K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | Arthrex, Inc. | 2006 | — |
| −1 | K141420 | Fastforward | MedShape, Inc. | 2014 | — |
| 0 (this device) | K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016 | — |
| +1 | K190926 | Hammertoe Truss System (HTS) | 4Web, Inc. | 2019 | — |
| +2 | K221283 | Hammertoe Truss System (HTS) | 4Web Medical, Inc. | 2022 | — |
| +3 | K231453 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2024 | — |
| +4 | K250613 | SnapHammer Hammertoe Correction System | Nvision Biomedical Technologies, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 8 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | K050259 | Arthrex Bio-PinSummary page 4…threx Bio-Pin (Marketed as Arthrex Trim-It™ Spin Pin) [510(k) K050259] Addional Predicates: • MedShape, Inc. Medshape FastForward… | 2005 |
| * | K141420 | FastforwardSummary page 4…Medshape FastForward (Marketed as MedShape Button) [510(k) K141420] • Synchro Medical, Inc. Synchro Medical (Ma… | 2014 |
| * | K133477 | Toegrip, Implant for Proximal Inter-Phalangeal ArthrodesisSummary page 4…Synchro Medical (Marketed as ToeGrip) [510(k) K133477] Description The Additive Orthopaedics Hammertoe Correction System is a monoblock non-circular shaft implant that is cannulated… | 2014 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190926 | Hammertoe Truss System (HTS) | 2019 | 3 |
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 37 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 50 ancestors have a recall of any class.
- Of its descendants, K190926 (4Web, Inc., 2019) has gone furthest, with 3 descendants of its own.
- 15 other devices also cite its predicate K050259.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures,
and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.
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/K160264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160264: Additive Orthopaedics 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/K160264
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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