510(k) · Cleared
ClearedTightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD
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 Dec 13, 2005 as substantially equivalent to K043248 (Arthrex, Inc., 2005) and 3 other predicates after a 71-day review. Its family tree reaches back 6 generations to 1979. 217 later devices descend from it.
- Decided
- Dec 13, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K792022 (1979). 39 ancestors in all. 217 later devices descend from it, 15 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 deviceK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- 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
- Descendant · cites it directly · 49 of its ownK112111 Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011
- Descendant · 2 generations on · 40 of its ownK113760 Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012
Showing 5 of 217 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 217 · See all- 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
- K112111Acu-Sinch Repair System and Acumed Suture AnchorAcumed, LLC · 2011 · cites it directly49descendants
- K113760Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks…Howmedica Osteonics Corp., Dba Stryker Orthopaedics · 2012 · 2 generations on40descendants
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) | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models… | Arthrex, Inc. | 2005 | — |
| +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 | — |
| +1 | K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | Acumed, LLC | 2011 | — |
| +2 | K113760 | Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax… | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2012 | — |
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 | 4 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 5 | 0 |
| 2014 | 14 | 0 |
| 2015 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 11 | 0 |
| 2018 | 12 | 0 |
| 2019 | 19 | 0 |
| 2020 | 16 | 0 |
| 2021 | 14 | 0 |
| 2022 | 19 | 0 |
| 2023 | 15 | 0 |
| 2024 | 24 | 0 |
| 2025 | 19 | 0 |
| 2026 | 23 | 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? (5)
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 1…bone fixation appliances and accessories: 21 CFR 888.3030 PREDICATE DEVICES K043248: TightRope Syndesmosis Device (Arthrex, Inc.) K023294: Bosworth Coraco-Clavicular Screw and Washer (Howmedica Osteonics) K041356:… | 2005 |
| * | K023294 | Bosworth Coraco-Clavicular ScrewSummary page 1…accessories: 21 CFR 888.3030 PREDICATE DEVICES K043248: TightRope Syndesmosis Device (Arthrex, Inc.) K023294: Bosworth Coraco-Clavicular Screw and Washer (Howmedica Osteonics) K041356: Tenodesis Family (Arthrex, Inc.) K003227: Bio-Absorba… | 2002 |
| * | K041356 | Arthrex Tenodesis Screw FamilySummary page 1…21 CFR 888.3030 PREDICATE DEVICES K043248: TightRope Syndesmosis Device (Arthrex, Inc.) K023294: Bosworth Coraco-Clavicular Screw and Washer (Howmedica Osteonics) K041356: Tenodesis Family (Arthrex, Inc.) K003227: Bio-Absorbable Corkscrew (Arthrex, Inc.) pre-1976, Kirschner (K)Wire (Synthes) DEVICE… | 2004 |
| * | K003227 | Bio-Absorbable Corkscrew Model AR-1920BSummary page 1…043248: TightRope Syndesmosis Device (Arthrex, Inc.) K023294: Bosworth Coraco-Clavicular Screw and Washer (Howmedica Osteonics) K041356: Tenodesis Family (Arthrex, Inc.) K003227: Bio-Absorbable Corkscrew (Arthrex, Inc.) pre-1976, Kirschner (K)Wire (Synthes) DEVICE DESCRIPTION AND INTENDED USE The TightRop… | 2001 |
| * | — | Kirschner (K)Wire Named without a submission number |
What descends from it? (217)
See all 21715 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112437 | Arthrex Fracture System | 2011 | 91 |
| K082095 | Ultraslide Acromioclavicular and Syndesmotic Repair Device | 2008 | 59 |
| K112111 | Acu-Sinch Repair System and Acumed Suture Anchor | 2011 | 49 |
| K070780 | Conmed Linvatec XO Button | 2007 | 38 |
| K061925 | Mini Tightrope Repair Kit, Model AR-8911DS | 2006 | 33 |
| K081098 | Endobutton Continuous Loop (CL) | 2008 | 31 |
| K220947 | Arthrex Knotless AC Repair Devices | 2022 | 3 |
| K132733 | Orthohelix Syndesmosis Fixation Devices | 2014 | 3 |
| K091207 | Surgicraft Lockdown Acromioclavicular (AC) Device | 2011 | 3 |
| K191319 | Dunamis Fixation Button System | 2019 | 1 |
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 39 ancestors have a recall of any class.
- Of its descendants, K112437 (Arthrex, Inc., 2011) has gone furthest, with 91 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.
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 TightRope TM Acromioclavicular (AC) 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 Acromioclavicular (AC) Device is intended to
provide fixation during the healing process following a syndesmotic trauma, such
as fixation of acromioclavicular separations due to coracoclavicular ligament
disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052776 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052776
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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