510(k) · Cleared
ClearedCoLink Sfx Implant System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In2bones USA, LLC · HTY Pin, Fixation, Smooth
Cleared on May 4, 2021 as substantially equivalent to K153204 (In2bones Sas, 2016) and 3 other predicates after a 137-day review. Its family tree reaches back 5 generations to 1996. 1 later device descends from it.
- Decided
- May 4, 2021
- Review
- 137 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K960385 (1996). 10 ancestors in all, the oldest K831072 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK960385 Sterile Kirschner Wires and Steinmann PinsDepuy, Inc. · 1996
- 4 generations backK022599 Newdeal K WireNew Deal, S.A. · 2002
- 3 generations backK101165 Pro-Toe VO Hammertow Implant SystemWrightmedicaltechnologyinc · 2010
- 2 generations backK120645 Pro-Toe (TM) VO Hamertoe Implant System-Line SdditionWrightmedicaltechnologyinc · 2012
- 1 generation backK132895 WMT Implantable K-WireWrightmedicaltechnologyinc · 2013
- This deviceK203698 CoLink Sfx Implant SystemIn2bones USA, LLC · 2021
- Descendant · cites it directly · 0 of its ownK231905 Electro-Spec Steri-CapsElectro-Spec, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231905Electro-Spec Steri-CapsElectro-Spec, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K960385 | Sterile Kirschner Wires and Steinmann Pins | Depuy, Inc. | 1996 | — |
| −4 | K022599 | Newdeal K Wire | New Deal, S.A. | 2002 | — |
| −3 | K101165 | Pro-Toe VO Hammertow Implant System | Wrightmedicaltechnologyinc | 2010 | — |
| −2 | K120645 | Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition | Wrightmedicaltechnologyinc | 2012 | — |
| −1 | K132895 | WMT Implantable K-Wire | Wrightmedicaltechnologyinc | 2013 | — |
| 0 (this device) | K203698 | CoLink Sfx Implant System | In2bones USA, LLC | 2021 | — |
| +1 | K231905 | Electro-Spec Steri-Caps | Electro-Spec, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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? (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 |
|---|---|---|---|
| * | K153204 | In2Bones Kirschner wireSummary page 5…ly cleared by the FDA: K203698 - Page 2 of 2 Primary Predicate x K153204 – In2Bones Kirschner Wire Additional Predicates x K022599 & K022597 – New Deal K Wire and K-Fix® x K132895 – Wright Medica… | 2016 |
| * | K022599 | Newdeal K WireSummary page 5…K203698 - Page 2 of 2 Primary Predicate x K153204 – In2Bones Kirschner Wire Additional Predicates x K022599 & K022597 – New Deal K Wire and K-Fix® x K132895 – Wright Medical WMT Implantable K-wires Reference Device x K163293 – CoL… | 2002 |
| * | K022597 | K-FIXSummary page 5…K203698 - Page 2 of 2 Primary Predicate x K153204 – In2Bones Kirschner Wire Additional Predicates x K022599 & K022597 – New Deal K Wire and K-Fix® x K132895 – Wright Medical WMT Implantable K-wires Reference Device x K163293 – CoLink® Plati… | 2002 |
| * | K132895 | WMT Implantable K-WireSummary page 5…K203698 - Page 2 of 2 Primary Predicate x K153204 – In2Bones Kirschner Wire Additional Predicates x K022599 & K022597 – New Deal K Wire and K-Fix® x K132895 – Wright Medical WMT Implantable K-wires Reference Device x K163293 – CoLink® Plating System Similar to the primary predicat… | 2013 |
| † | K163293 | Colink™ Plating System | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231905 | Electro-Spec Steri-Caps | 2023 | 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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.6 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K231905 (Electro-Spec, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K153204.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 In2Bones USA CoLink® Sfx Implant System is a system of implantable K-wires and caps indicated for temporary fixation and stabilization of bone fractures and reconstructions. In addition, the K-wires can be used as guide pins for insertion of other implants. The caps are indicated for use in the protection of protruding ends of wires.
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/K203698 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203698: CoLink Sfx Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203698
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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