510(k) · Cleared
ClearedSynthes (U.S.a.) Polypin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · HTY Pin, Fixation, Smooth
Cleared on May 9, 1997 after a 379-day review. The FDA summary names its predicate without a number. 577 later devices descend from it.
- Decided
- May 9, 1997
- Review
- 379 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 0
577 later devices descend from it, 4 citing it directly.
- This deviceK961608 Synthes (U.S.a.) PolypinSynthes (Usa) · 1997
- Descendant · cites it directly · 419 of its ownK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- Descendant · 2 generations on · 413 of its ownK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- Descendant · cites it directly · 382 of its ownK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
- Descendant · 2 generations on · 337 of its ownK012001 SmartscrewBionx Implants, Ltd. · 2001
- Descendant · 3 generations on · 333 of its ownK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
Showing 5 of 577 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 577 · See all- K974876Bionx Distal Radius ScrewBionx Implants, Inc. · 1998 · cites it directly419descendants
- K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999 · 2 generations on413descendants
- K031712Inion Otps Biodegradable PinInion, Ltd. · 2003 · cites it directly382descendants
- K012001SmartscrewBionx Implants, Ltd. · 2001 · 2 generations on337descendants
- K030900Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003 · 3 generations on333descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961608 | Synthes (U.S.a.) Polypin | Synthes (Usa) | 1997 | — |
| +1 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| +2 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| +1 | K031712 | Inion Otps Biodegradable Pin | Inion, Ltd. | 2003 | — |
| +2 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| +3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 7 | 0 |
| 2003 | 4 | 0 |
| 2004 | 7 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 7 | 0 |
| 2008 | 12 | 0 |
| 2009 | 11 | 0 |
| 2010 | 4 | 0 |
| 2011 | 10 | 0 |
| 2012 | 7 | 0 |
| 2013 | 14 | 0 |
| 2014 | 28 | 0 |
| 2015 | 18 | 0 |
| 2016 | 13 | 0 |
| 2017 | 26 | 0 |
| 2018 | 23 | 0 |
| 2019 | 39 | 0 |
| 2020 | 35 | 0 |
| 2021 | 31 | 0 |
| 2022 | 34 | 0 |
| 2023 | 52 | 0 |
| 2024 | 58 | 0 |
| 2025 | 57 | 0 |
| 2026 | 54 | 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? (4)
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 |
|---|---|---|---|
| * | — | Kirschner wires Named without a submission number | |
| * | — | small screws Named without a submission number | |
| * | — | Johnson & Johnson OrthoSorb® Absorbable Pin Named without a submission number | |
| * | — | Biosciences, Inc. BIOFIX® Bioabsorbable Pin Named without a submission number |
What descends from it? (577)
See all 5774 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K974876 (Bionx Implants, Inc., 1998) has gone furthest, with 419 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 Polypin is intended for use in the fixation of small bone fragments in cases of low-load fractures, such as apical fragments, osteochondral fragments and cancellous/non-load-bearing fragments. Specific applications include the following:
Apical fragments: radial head
patellar rim
navicular
metacarpal/metatersal * proximal or distal ends)
Osteochondral fragments: talus vault
temoral condyle
Spongy/non-load bearing fragments: talus
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/K961608 · printed Nov 5, 2026
Cite this page
510(k) Report. “K961608: Synthes (U.S.a.) Polypin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K961608
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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