510(k) · Cleared
ClearedStarFuse Interphalangeal Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phalanx Innovations · HTY Pin, Fixation, Smooth
Cleared on Apr 26, 2016 as substantially equivalent to K112675 (Arrowhead Medical Device Technologies, LLC, 2011) after a 90-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Apr 26, 2016
- Review
- 90 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K983121 (1998). 14 ancestors in all, the oldest K960385 (1996). No later device cites it as a predicate yet.
- Root · 6 generations backK983121 Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S…Syntec Scientific Corp. · 1998
- 5 generations backK993910 Tac' PinNew Deal, S.A. · 2000
- 4 generations backK051740 Tapered Compression PinNexa Orthopedics, Inc. · 2005
- 3 generations backK072710 Nexfix Compression PinNexa Orthopedics, Inc. · 2007
- 2 generations backK100926 Arrowhead Fixation DeviceArrow Products, Inc. · 2010
- 1 generation backK112675 Arrow-Lok Digital SystemArrowhead Medical Device Technologies, LLC · 2011 · Recalled
- This deviceK160194 StarFuse Interphalangeal PinPhalanx Innovations · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160… | Syntec Scientific Corp. | 1998 | — |
| −5 | K993910 | Tac' Pin | New Deal, S.A. | 2000 | — |
| −4 | K051740 | Tapered Compression Pin | Nexa Orthopedics, Inc. | 2005 | — |
| −3 | K072710 | Nexfix Compression Pin | Nexa Orthopedics, Inc. | 2007 | — |
| −2 | K100926 | Arrowhead Fixation Device | Arrow Products, Inc. | 2010 | — |
| −1 | K112675 | Arrow-Lok Digital System | Arrowhead Medical Device Technologies, LLC | 2011 | 1 |
| 0 (this device) | K160194 | StarFuse Interphalangeal Pin | Phalanx Innovations | 2016 | — |
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 |
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? (1)
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 |
|---|---|---|---|
| * | K112675 | Arrow-Lok Digital SystemSummary page 4…Class II Regulation Number 21 CFR 888.3040 Product Code HTY Name of Predicate Device 510(k) # Manufacturer ARROW-LOK Digital Fusion K112675 Arrowhead Medical Device Technologies, System LLC Description The StarFu… | 2011 |
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 18 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
- 2 other devices also cite its predicate K112675.
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 StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160194 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160194: StarFuse Interphalangeal Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160194
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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