510(k) · Cleared
ClearedArthrex Bio-Pin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTY Pin, Fixation, Smooth
Cleared on May 27, 2005 after a 113-day review. The FDA summary names no predicate by number. 31 later devices descend from it.
- Decided
- May 27, 2005
- Review
- 113 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
31 later devices descend from it, 16 citing it directly.
- This deviceK050259 Arthrex Bio-PinArthrex, Inc. · 2005
- Descendant · cites it directly · 16 of its ownK110445 Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · Recalled
- Descendant · cites it directly · 9 of its ownK122031 Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012
- Descendant · cites it directly · 4 of its ownK160264 Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016
- Descendant · 2 generations on · 4 of its ownK130859 Hammertoe Correction SystemArthrosurface, Inc. · 2013
- Descendant · 2 generations on · 3 of its ownK200840 DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · Recalled
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K110445Flexfusion (TM) Fixation ImplantNextremity Solutions, LLC · 2011 · cites it directly16descendants
- K122031Nextra TI Hammertoe Correction SystemNextremity Solutions, LLC · 2012 · cites it directly9descendants
- K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC · 2016 · cites it directly4descendants
- K130859Hammertoe Correction SystemArthrosurface, Inc. · 2013 · 2 generations on4descendants
- K200840DuoHex CH Cannulated Hammertoe SystemNextremity Solutions, Inc. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K050259 | Arthrex Bio-Pin | Arthrex, Inc. | 2005 | — |
| +1 | K110445 | Flexfusion (TM) Fixation Implant | Nextremity Solutions, LLC | 2011 | 6 |
| +1 | K122031 | Nextra TI Hammertoe Correction System | Nextremity Solutions, LLC | 2012 | — |
| +1 | K160264 | Additive Orthopaedics Hammertoe Correction System | Additive Orthopaedics, LLC | 2016 | — |
| +2 | K130859 | Hammertoe Correction System | Arthrosurface, Inc. | 2013 | — |
| +2 | K200840 | DuoHex CH Cannulated Hammertoe System | Nextremity Solutions, Inc. | 2020 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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?
The FDA summary names no predicate by number.
What descends from it? (31)
See all 3116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110445 | Flexfusion (TM) Fixation Implant | 2011 | 16 |
| K122031 | Nextra TI Hammertoe Correction System | 2012 | 9 |
| K160264 | Additive Orthopaedics Hammertoe Correction System | 2016 | 4 |
| K153065 | The Hammertoe Correction System | 2016 | 2 |
| K142490 | ProxiFuse Hammer Toe Device | 2014 | 2 |
| K133515 | Peek Fusion Implant | 2014 | 2 |
| K253325 | ZipToe™ Hammertoe Fusion System | 2025 | 0 |
| K211996 | Nexta PEEK Hammertoe Correction System | 2021 | 0 |
| K171448 | Hammertoe Correction System | 2017 | 0 |
| K162685 | 2-Piece Hammertoe Correction System | 2017 | 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?
- Of its descendants, K110445 (Nextremity Solutions, LLC, 2011) has gone furthest, with 16 descendants of its own.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and…
Read the full statement (130 words)
The Arthrex Bio-Pins are poly-L-Lactide based implants used to fix small bony or apical chondral fragments in the Foot, Ankle, Upper Extremities, Hand, and Wrist, where such fragments are not under tension or load-bearing. These pins are used in cases of osteochondritis dissecans and osteochondral fragments, fixation of fractures, 1st metatarsal (bunionectomy osteotomies), upper extremity fractures, cuneiform bones, inherently stable osteotomies, and fusions of the phalanges, metatarsals, metacarpals, carpal bones, tarsal bones, ankle, and wrist. The Bio-Pins can be used for inherently stable intramedullary stabilization of joint arthroplasty (resection) or fusion for the treatment of digital deformities of the foot or hand. The Bio-Pin is also used in inherently stable long bone fractures such as the femur, fibula, tibia, humerus, radius and ulna including the diaphyseal, epiphyseal, and metaphyseal areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050259 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050259: Arthrex Bio-Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050259
Report an extraction error
Are you the manufacturer?
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