510(k) · Cleared
ClearedTightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrex, Inc. · HTN Washer, Bolt Nut
Cleared on Feb 16, 2005 as substantially equivalent to K033717 (Bonutti Research, Inc., 2004) and 4 other predicates after an 85-day review. Its family tree reaches back 5 generations to 1979. 306 later devices descend from it.
- Decided
- Feb 16, 2005
- Review
- 85 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K792022 (1979). 35 ancestors in all. 306 later devices descend from it, 26 citing it directly.
- Root · 5 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 4 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 3 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 2 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 1 generation backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- This deviceK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- Descendant · cites it directly · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- Descendant · cites it directly · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled
- Descendant · cites it directly · 91 of its ownK112437 Arthrex Fracture SystemArthrex, Inc. · 2011
- Descendant · 2 generations on · 71 of its ownK123241 Arthrex Fracture PlatesArthrex, Inc. · 2013
- Descendant · cites it directly · 59 of its ownK082095 Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008
Showing 5 of 306 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 306 · See all- K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · cites it directly217descendants
- K083070Toggleloc SystemBiomet Sports Medicine · 2008 · cites it directly94descendants
- K112437Arthrex Fracture SystemArthrex, Inc. · 2011 · cites it directly91descendants
- K123241Arthrex Fracture PlatesArthrex, Inc. · 2013 · 2 generations on71descendants
- K082095Ultraslide Acromioclavicular and Syndesmotic Repair DeviceSmith & Nephew Endoscopy, Inc. · 2008 · cites it directly59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −4 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −3 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −2 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −1 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| 0 (this device) | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.… | Arthrex, Inc. | 2005 | — |
| +1 | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +1 | K083070 | Toggleloc System | Biomet Sports Medicine | 2008 | 6 |
| +1 | K112437 | Arthrex Fracture System | Arthrex, Inc. | 2011 | — |
| +2 | K123241 | Arthrex Fracture Plates | Arthrex, Inc. | 2013 | — |
| +1 | K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | Smith & Nephew Endoscopy, Inc. | 2008 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 7 | 0 |
| 2014 | 18 | 0 |
| 2015 | 9 | 0 |
| 2016 | 6 | 0 |
| 2017 | 15 | 0 |
| 2018 | 15 | 0 |
| 2019 | 26 | 0 |
| 2020 | 22 | 0 |
| 2021 | 22 | 0 |
| 2022 | 22 | 0 |
| 2023 | 26 | 0 |
| 2024 | 35 | 0 |
| 2025 | 30 | 0 |
| 2026 | 34 | 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? (6)
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 |
|---|---|---|---|
| * | K033717 | Transet Fracture Fixation SystemSummary page 1…GAT: Nonabsorbable poly (ethylene terephthalate) surgical suture: 21 CFR 878.5000 PREDICATE DEVICES K033717: TranSet Tm Fracture Fixation System (Bonutti) K963172: 4.0 / 4.5 mm Screw (Synthes) K003077: SmartScreWTM. Bionx Implants, Ltd.… | 2004 |
| * | K963172 | Synthes Sterile 4.5 MM Cannulated ScrewsSummary page 1…ylene terephthalate) surgical suture: 21 CFR 878.5000 PREDICATE DEVICES K033717: TranSet Tm Fracture Fixation System (Bonutti) K963172: 4.0 / 4.5 mm Screw (Synthes) K003077: SmartScreWTM. Bionx Implants, Ltd. (Linvatec) K030900, OTPSTM Biodegradable Fixation Syste… | 1996 |
| * | K003077 | Smartscrew Model 222006...227510Summary page 1…surgical suture: 21 CFR 878.5000 PREDICATE DEVICES K033717: TranSet Tm Fracture Fixation System (Bonutti) K963172: 4.0 / 4.5 mm Screw (Synthes) K003077: SmartScreWTM. Bionx Implants, Ltd. (Linvatec) K030900, OTPSTM Biodegradable Fixation System (Inion Ltd.) K984550, EndoButton (Sm… | 2001 |
| * | K030900 | Inion Otps Biodegradable Fixaton SystemSummary page 1…00 PREDICATE DEVICES K033717: TranSet Tm Fracture Fixation System (Bonutti) K963172: 4.0 / 4.5 mm Screw (Synthes) K003077: SmartScreWTM. Bionx Implants, Ltd. (Linvatec) K030900, OTPSTM Biodegradable Fixation System (Inion Ltd.) K984550, EndoButton (Smith & Nephew) pre-1976, Kirschner (K)Wire (Synthes) DE… | 2003 |
| * | K984550 | Pre-Threaded EndobuttonSummary page 1…System (Bonutti) K963172: 4.0 / 4.5 mm Screw (Synthes) K003077: SmartScreWTM. Bionx Implants, Ltd. (Linvatec) K030900, OTPSTM Biodegradable Fixation System (Inion Ltd.) K984550, EndoButton (Smith & Nephew) pre-1976, Kirschner (K)Wire (Synthes) DEVICE DESCRIPTION AND INTENDED USE The TightRope TM Syndlesm… | 1999 |
| * | — | Kirschner (K)Wire (Synthes) Named without a submission number |
What descends from it? (306)
See all 30626 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257… | 2005 | 217 |
| K083070 | Toggleloc System | 2008 | 94 |
| K112437 | Arthrex Fracture System | 2011 | 91 |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | 2008 | 59 |
| K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | 2006 | 33 |
| K201522 | Arthrex Syndesmosis TightRope XP Buttress Plate Implant System | 2020 | 7 |
| K191783 | Parcus Synd-EZ Ti | 2019 | 5 |
| K162805 | Akros Fibulink Syndesmosis Repair Kit | 2017 | 5 |
| K131850 | Tensyn Band | 2013 | 5 |
| 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 26 years and passes through 5 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 35 ancestors have a recall of any class.
- Of its descendants, K052776 (Arthrex, Inc., 2005) has gone furthest, with 217 descendants of its own.
- 1 other device also cites its predicate K033717.
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 Arthrex TightRopeTM 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 Arthrex TightRope TM 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/K043248 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043248
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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