510(k) · Cleared
ClearedVeriFixx™ Small Bone Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Armis Biopharma, Inc. · HTY Pin, Fixation, Smooth
Cleared on Nov 17, 2020 as substantially equivalent to K133636 (Extremity Medical, LLC, 2014) and 1 other predicate after a 56-day review. Its family tree reaches back 5 generations to 1990.
- Decided
- Nov 17, 2020
- Review
- 56 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K901456 (1990). 34 ancestors in all, the oldest K792670 (1980). No later device cites it as a predicate yet.
- Root · 5 generations backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
- 4 generations backK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- 3 generations backK050275 Modification to: Inion Otps Biodegradable PinInion, Ltd. · 2005
- 2 generations backK061164 ActivapinBioretec, Ltd. · 2006
- 1 generation backK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
- This deviceK202777 VeriFixx™ Small Bone ImplantArmis Biopharma, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −4 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| −3 | K050275 | Modification to: Inion Otps Biodegradable Pin | Inion, Ltd. | 2005 | — |
| −2 | K061164 | Activapin | Bioretec, Ltd. | 2006 | — |
| −1 | K133636 | Extremity Medical Hammertoe Device | Extremity Medical, LLC | 2014 | — |
| 0 (this device) | K202777 | VeriFixx™ Small Bone Implant | Armis Biopharma, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K133636 | Extremity Medical Hammertoe DeviceSummary page 4…which conforms to ASTM F2026 and coated with commercially pure (CP) titanium (ASTM F67). Primary HammerFix™ (Extremity Medical, LLC) (K133636) Predicate: Secondary HammerTube™ (Paragon 28, Inc.) (K171715) Predicate:… | 2014 |
| * | K171715 | HammerTube SystemSummary page 4…(CP) titanium (ASTM F67). Primary HammerFix™ (Extremity Medical, LLC) (K133636) Predicate: Secondary HammerTube™ (Paragon 28, Inc.) (K171715) Predicate: Page 1 of 2… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 30 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- 4 of the 34 ancestors have a recall of any class.
- 8 other devices also cite its predicate K133636.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 VeriFixx™ Small Bone Implant 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/K202777 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202777: VeriFixx™ Small Bone Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202777
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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