510(k) · Cleared
ClearedFlex-Nails
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fixano SA · HTY Pin, Fixation, Smooth
Cleared on Aug 24, 2001 as substantially equivalent to K960385 (Depuy, Inc., 1996) and 1 other predicate after a 44-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 24, 2001
- Review
- 44 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960385 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- This deviceK012161 Flex-NailsFixano SA · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| 0 (this device) | K012161 | Flex-Nails | Fixano SA | 2001 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 |
|---|---|---|---|
| * | K960385 | Sterile Kirschner Wires and Steinmann PinsSummary page 1…ification Number: 21 CFR 888.3040/Procode 87 HTY Substantial Equivalence: DePuy Nancy Nail preamendment device, DePuy Sterile Kirschner Wires and Steinmann Pins device (K960385) Syntec-Taichung Non- sterile Kirschner Wires and Steinmann Pins (K983121) Device Description: The device is a flexible titaniu… | 1996 |
| * | K983121 | Non-Sterile Kirschner Wires and Steinmann Pins, Models #'S 290-101/160, 290-201/216…Summary page 1…ePuy Nancy Nail preamendment device, DePuy Sterile Kirschner Wires and Steinmann Pins device (K960385) Syntec-Taichung Non- sterile Kirschner Wires and Steinmann Pins (K983121) Device Description: The device is a flexible titanium nail for orthopedic implantation. Intended Use: The intended use is simi… | 1998 |
| * | — | DePuy Nancy Nail preamendment device Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 16 other devices also cite its predicate K960385.
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?
Fixano FLEX-NAILS are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants, or implantation through the skin so that traction may be applied to the skeletal system.
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/K012161 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012161: Flex-Nails.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012161
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026