# K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew Endoscopy, Inc.
- Decided: Oct 21, 2008 after 89 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K792022 (1979). 40 ancestors in all.
59 later devices descend from it; 3 cite it directly.
0 of 100 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 1.
- K043248: Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model AR-8921DS, Arthrex, Inc. (2005) Summary page 1.

## Most influential descendants
- K112111: Acu-Sinch Repair System and Acumed Suture Anchor (2011), 49 descendants of its own
- K113760: Variax Superior and Anterior, Lateral and Midshaft Clavicle Plates Variax Aiming Blocks & Joystick (2012), 40 descendants of its own
- K132502: Variax 2 System (2013), 21 descendants of its own
- K140769: Variax 2 System (2014), 19 descendants of its own
- K130116: Superior Lateral Variax Clavicle Plate (2013), 16 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K082095
Methodology: https://510kreport.com/methodology