510(k) · Cleared
ClearedUltraslide Acromioclavicular and Syndesmotic Repair Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew Endoscopy, Inc. · HTN Washer, Bolt Nut
Cleared on Oct 21, 2008 as substantially equivalent to K052776 (Arthrex, Inc., 2005) and 1 other predicate after an 89-day review. Its family tree reaches back 7 generations to 1979. 59 later devices descend from it.
- Decided
- Oct 21, 2008
- Review
- 89 days
- Class
- Class II
- Product code
- HTN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K792022 (1979). 40 ancestors in all. 59 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 6 generations backK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- 5 generations backK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
- 4 generations backK012001 SmartscrewBionx Implants, Ltd. · 2001
- 3 generations backK030900 Inion Otps Biodegradable Fixaton SystemInion, Ltd. · 2003
- 2 generations backK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
- 1 generation backK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
- This deviceK082095 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
- Descendant · 3 generations on · 21 of its ownK132502 Variax 2 SystemStryker Trauma AG · 2013
- Descendant · 4 generations on · 19 of its ownK140769 Variax 2 SystemStryker Trauma AG · 2014
- Descendant · 3 generations on · 16 of its ownK130116 Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- 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
- K132502Variax 2 SystemStryker Trauma AG · 2013 · 3 generations on21descendants
- K140769Variax 2 SystemStryker Trauma AG · 2014 · 4 generations on19descendants
- K130116Superior Lateral Variax Clavicle PlateStryker Trauma AG · 2013 · 3 generations on16descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −6 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| −5 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
| −4 | K012001 | Smartscrew | Bionx Implants, Ltd. | 2001 | — |
| −3 | K030900 | Inion Otps Biodegradable Fixaton System | Inion, Ltd. | 2003 | — |
| −2 | 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 | — |
| 0 (this device) | 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 | — |
| +3 | K132502 | Variax 2 System | Stryker Trauma AG | 2013 | — |
| +4 | K140769 | Variax 2 System | Stryker Trauma AG | 2014 | — |
| +3 | K130116 | Superior Lateral Variax Clavicle Plate | Stryker Trauma AG | 2013 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 10 | 0 |
| 2025 | 9 | 0 |
| 2026 | 4 | 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? (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 |
|---|---|---|---|
| * | K052776 | Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Summary page 1…scientific technology to the following legally marketed devices in commercial distribution: Arthrex TightropeTM Acromioclavicular (AC) Device (cleared via K052776) and the Arthrex Tightrope TM Syndesmosis Device (cleared via K043248). Pave 28 o… | 2005 |
| * | K043248 | Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Summary page 1…mmercial distribution: Arthrex TightropeTM Acromioclavicular (AC) Device (cleared via K052776) and the Arthrex Tightrope TM Syndesmosis Device (cleared via K043248). Pave 28 of 56… | 2005 |
What descends from it? (59)
See all 593 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 6 companies; a new generation was cleared every 1.8 years on median.
- 2 of the 40 ancestors have a recall of any class.
- Of its descendants, K112111 (Acumed, LLC, 2011) has gone furthest, with 49 descendants of its own.
- 14 other devices also cite its predicate K052776.
How does its category compare?
All HTN devicesHTN Washer, Bolt Nut: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Smith & Nephew Ultraslide Acromioclavicular and Syndesmotic Repair Device is intended as an adjunct in fracture repair providing fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions or fixation of ankle syndesmosis due to anterior inferior tibiofibular ligament and/or posterior inferior tibiofibular ligament disruptions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082095 · printed Nov 4, 2026
Cite this page
510(k) Report. “K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K082095
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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