510(k) · Cleared
ClearedSportLinc Syndesmosis Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lincotek Medical · HTN Washer, Bolt Nut
Cleared on Mar 27, 2026 as substantially equivalent to K043248 (Arthrex, Inc., 2005) and 1 other predicate after a 268-day review. Its family tree reaches back 9 generations to 1990.
- Decided
- Mar 27, 2026
- Review
- 268 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 9 generations to K904436 (1990). 61 ancestors in all, the oldest K792022 (1979). No later device cites it as a predicate yet.
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 5 generations between
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK252081 SportLinc Syndesmosis DeviceLincotek Medical · 2026
Show all 9 generations
- Root · 9 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 8 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 7 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 6 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 5 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 4 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 3 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 2 generations backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- 1 generation backK130033 Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit…Biomet Manufacturing Corp · 2013 · Recalled
- This deviceK252081 SportLinc Syndesmosis DeviceLincotek Medical · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −8 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −7 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −6 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −5 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −4 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −3 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −2 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| −1 | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc… | Biomet Manufacturing Corp | 2013 | 3 |
| 0 (this device) | K252081 | SportLinc Syndesmosis Device | Lincotek Medical | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1982 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 3 | 0 |
| 1998 | 5 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 7 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 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 16.4 · 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? (2)
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 |
|---|---|---|---|
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 5…21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K043248 TightRope Syndesmosis Device HTN I K130033… | 2005 |
| * | K130033 | Toggleloc Xtender; Toggleloc XL; Implant Kit Toggleloc; Implant Kit Toggleloc BTB…Summary page 5…rst) Product Code K043248 TightRope Syndesmosis Device HTN I K130033 I I ToggleLoc System (ZipTight) I I MBI I Dev… | 2013 |
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?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 2.9 years on median.
- 10 of the 61 ancestors have a recall of any class.
- 25 other devices also cite its predicate K043248.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
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 Lincotek SportLinc Syndesmosis Device is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.
Specifically, the Lincotek SportLinc Syndesmosis Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber B and C ankle fractures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252081 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252081: SportLinc Syndesmosis Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252081
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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