510(k) · Cleared
ClearedHex Button
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology · HTN Washer, Bolt Nut
Cleared on Oct 27, 1999 as substantially equivalent to K974016 (Pioneer Surgical Technology, 1997) after an 84-day review. Its family tree reaches back 1 generation to 1997. 10 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 84 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K974016 (1997). 10 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK974016 Cerclage Cable with Hex ButtonPioneer Surgical Technology · 1997
- This deviceK992617 Hex ButtonPioneer Surgical Technology · 1999
- Descendant · cites it directly · 7 of its ownK091799 Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009
- Descendant · 2 generations on · 6 of its ownK120772 NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button…Zimmer GmbH · 2012 · Recalled
- Descendant · 3 generations on · 1 of its ownK210247 OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021
- Descendant · cites it directly · 0 of its ownK261271 Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026
- Descendant · 3 generations on · 0 of its ownK261038 Xpert PFPNewclip Technics · 2026
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K091799Cable Ready Cable Grip System Cable ButtonZimmer, Inc. · 2009 · cites it directly7descendants
- K120772NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB Oplyaxial…Zimmer GmbH · 2012 · 2 generations on6descendants
- K210247OsteoCentric Integrated Hip Fastener SystemOsteocentric Technologies D.B.A. Osteocentric Trauma · 2021 · 3 generations on1descendant
- K261271Cable-Ready® Cable Grip SystemPioneer Surgical Technology, Inc. · 2026 · cites it directly0descendants
- K261038Xpert PFPNewclip Technics · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K974016 | Cerclage Cable with Hex Button | Pioneer Surgical Technology | 1997 | — |
| 0 (this device) | K992617 | Hex Button | Pioneer Surgical Technology | 1999 | — |
| +1 | K091799 | Cable Ready Cable Grip System Cable Button | Zimmer, Inc. | 2009 | — |
| +2 | K120772 | NCB Periprosthetic Trochanter Plates and Screws, NCB Cable Button for NCB… | Zimmer GmbH | 2012 | 2 |
| +3 | K210247 | OsteoCentric Integrated Hip Fastener System | Osteocentric Technologies D.B.A. Osteocentric Trauma | 2021 | — |
| +1 | K261271 | Cable-Ready® Cable Grip System | Pioneer Surgical Technology, Inc. | 2026 | — |
| +3 | K261038 | Xpert PFP | Newclip Technics | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 HTN? 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 HTN device
- #1 K201522 Arthrex Syndesmosis TightRope XP Buttress…score 16.5 · 6 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 |
|---|---|---|---|
| * | K974016 | Cerclage Cable with Hex ButtonSummary page 2…ulation Number: CFR 888.3030 Classification Number: 87HTN Device Class: I Devices on Which Substantial Equivalence is Claimed: Cerclage Cable with Hex Button Device (K974016) Device Description The Hex Button is a device that is used with a cerclage device and bone screws. The Hex Button device links… | 1997 |
What descends from it? (10)
3 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?
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HTN
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTN
75in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTN
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTN
190in 2025
MAUDE reports naming product code HTN, 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 | 1 | — | 0 | 14 |
| 2008 | 2 | — | 0 | 11 |
| 2009 | 3 | 86 | 0 | 22 |
| 2010 | 0 | — | 0 | 17 |
| 2011 | 4 | 130 | 0 | 12 |
| 2012 | 0 | — | 0 | 69 |
| 2013 | 3 | 105 | 1 | 45 |
| 2014 | 8 | 98 | 0 | 33 |
| 2015 | 2 | — | 0 | 35 |
| 2016 | 1 | — | 0 | 43 |
| 2017 | 6 | 88 | 0 | 30 |
| 2018 | 2 | — | 0 | 48 |
| 2019 | 5 | 116 | 1 | 53 |
| 2020 | 3 | 87 | 0 | 81 |
| 2021 | 2 | — | 0 | 149 |
| 2022 | 5 | 86 | 0 | 85 |
| 2023 | 2 | — | 0 | 108 |
| 2024 | 6 | 90 | 0 | 269 |
| 2025 | 4 | 75 | 0 | 190 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Hex Button device is indicated for fractures that may not be securely held by either a screw or a cerclage device alone.
The Hex Button device is intended for use where wire, cable, or band cerclage is used in combination with bone screws and/or plates, of the same material type, to provide internal fixation of fractured bone.
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/K992617 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992617: Hex Button.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992617
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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