510(k) · Cleared
ClearedAkros Fibulink Syndesmosis Repair Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Akros Medical · HTN Washer, Bolt Nut
Cleared on Jan 10, 2017 as substantially equivalent to K043248 (Arthrex, Inc., 2005) after a 97-day review. Its family tree reaches back 6 generations to 1979. 5 later devices descend from it.
- Decided
- Jan 10, 2017
- Review
- 97 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K792022 (1979). 36 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 5 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 4 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 3 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 2 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 1 generation backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- This deviceK162805 Akros Fibulink Syndesmosis Repair KitAkros Medical · 2017
- Descendant · cites it directly · 4 of its ownK173550 Akros FibuLink™ Syndesmosis Repair KitAkros Medical · 2017
- Descendant · 2 generations on · 3 of its ownK211770 R3ACT Stabilization SystemParagon 28, Inc. · 2021
- Descendant · 3 generations on · 2 of its ownK223589 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023
- Descendant · 4 generations on · 1 of its ownK240594 Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024
- Descendant · 5 generations on · 0 of its ownK253886 Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026
Most influential descendants
Showing 5 of 5 · See all- K173550Akros FibuLink™ Syndesmosis Repair KitAkros Medical · 2017 · cites it directly4descendants
- K211770R3ACT Stabilization SystemParagon 28, Inc. · 2021 · 2 generations on3descendants
- K223589Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2023 · 3 generations on2descendants
- K240594Grappler Suture Anchor R3FLEX IOL SystemParagon 28, Inc. · 2024 · 4 generations on1descendant
- K253886Grappler Suture Anchor PCFD Tether SystemParagon 28, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −5 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −4 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −3 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −2 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −1 | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| 0 (this device) | K162805 | Akros Fibulink Syndesmosis Repair Kit | Akros Medical | 2017 | — |
| +1 | K173550 | Akros FibuLink™ Syndesmosis Repair Kit | Akros Medical | 2017 | — |
| +2 | K211770 | R3ACT Stabilization System | Paragon 28, Inc. | 2021 | — |
| +3 | K223589 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2023 | — |
| +4 | K240594 | Grappler Suture Anchor R3FLEX IOL System | Paragon 28, Inc. | 2024 | — |
| +5 | K253886 | Grappler Suture Anchor PCFD Tether System | Paragon 28, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 7 | 0 |
| 1997 | 4 | 0 |
| 1998 | 2 | 0 |
| 1999 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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 16.5 · 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 |
|---|---|---|---|
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 4…fixation appliances and accessories; Class II Product Code: 87/HTN Predicate Device: Arthrex TightRopeTM Syndesmosis Device, K043248 Device Description: The Akros FibuLink™ Syndesmosis Repair Kit is a multiple-anchor orthopedic fixation device system, offered… | 2005 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173550 | Akros FibuLink™ Syndesmosis Repair Kit | 2017 | 4 |
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 38 years and passes through 6 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 36 ancestors have a recall of any class.
- Of its descendants, K173550 (Akros Medical, 2017) has gone furthest, with 4 descendants of its own.
- 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. 2017, 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 Akros FibuLink™ Syndesmosis Repair Kit is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated and as an adjunct to fixation systems involving plates, with fracture braces and casting. Specifically, the Akros FibuLink™ Syndesmosis Repair Kit 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/K162805 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162805: Akros Fibulink Syndesmosis Repair Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162805
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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