# K112111: Acu-Sinch Repair System and Acumed Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Acumed, LLC
- Decided: Nov 14, 2011 after 112 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: 8 generations back to K792022 (1979). 52 ancestors in all.
49 later devices descend from it; 5 cite it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082095: Ultraslide Acromioclavicular and Syndesmotic Repair Device, Smith & Nephew Endoscopy, Inc. (2008) Summary page 2.
- K052776: Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257, AR-TBD, Arthrex, Inc. (2005) Summary page 2.
- K012655: Congruent Bone Plate System, Acu Med, Inc. (2001) Summary page 2.
- K061665: Arthrex 4.5 MM, 5.5 MM and 6.5 MM Corkscrew FT, Arthrex, Inc. (2006) Summary page 2.

## Most influential descendants
- 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
- K173135: VariAx 2 System (2017), 13 descendants of its own

## Indications for use
The Acu-Sinch Repair System is intended to be used in conjunction with a clavicle plate of the Congruent Bone Plate System to provide fixation during the healing of clavicle fractures. The Acu-Sinch Repair System also may be used as a stand-alone system for treatment of acromioclavicular and/or coracoclavicular ligament disruption. The Acumed Suture Anchor is intended for fixation of suture to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in the following procedures: * Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction * Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair * Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Iliotibial Band Tenodesis * Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction * Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction Acumed's Locking Clavicle Plating System is designed to provide fixation during fractures, fusions, or osteotomies of the clavicle.

Source page: https://510kreport.com/device/K112111
Methodology: https://510kreport.com/methodology