# K091870: Tornier, Piton Fixation Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier
- Decided: Sep 21, 2009 after 90 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 K921873 (1992). 22 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080335: Tornier Cinch Knotless Fixation Implant System, Tornier, Inc. (2008) Summary page 1.
- K053344: Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture Anchor, Smith & Nephew, Inc. (2006) Summary page 1.

## Most influential descendants
- K110773: Tornier Insite FT Suture Anchor (2011), 5 descendants of its own
- K150715: 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors (2015), 2 descendants of its own
- K201636: Hercules Suture Anchor System (2020), 1 descendant of its own
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants of its own
- K133777: Tornier Insite (TM) FT Peek Knotless Suture Anchor (2014), 0 descendants of its own

## Indications for use
The Tornier PITON™ Fixation Implant is intended for fixation of soft tissue to bone. The PITON™ Implant is intended for use in the following applications: Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulabral Reconstruction Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Illiotibial Band Tenodesis Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency Hip: Capsular Repair - Acetabular Labral Repair

Source page: https://510kreport.com/device/K091870
Methodology: https://510kreport.com/methodology