# K103262: Quickdraw Convertible Fixation Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Apr 5, 2011 after 152 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961555 (1996). 18 ancestors in all.
No later device cites it as a predicate yet.
0 of 19 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 1.
- K061349: Opus Labralock P Knotless Fixation Device, Arthrocare Corp. (2006) Summary page 1.

## Indications for use
The Tornier, 3.4mm QuickDraw™ Convertible Fixation Implant is intended for use in arthroscopic or mini-open surgical procedures either as a standard bone anchor or as a knotless system for fixation of soft tissue to bone. The QuickDraw™ Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, Anterior Shoulder Stabilization, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction Foot/Ankle: Lateral or Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair, Bunionectomy Elbow, Wrist and Hand: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair Knee: Extra-capsular Repairs, Patellar Realignment and Tendon Repairs, Iliotibial Band Tenodesis

Source page: https://510kreport.com/device/K103262
Methodology: https://510kreport.com/methodology