# K132632: Tornier Insite FT Suture Anchor with Needles

- Pathway: 510(k) (Special)
- Applicant: Tornier, Inc.
- Decided: Sep 19, 2013 after 28 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: 7 generations back to K921873 (1992). 39 ancestors in all.
No later device cites it as a predicate yet.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110773: Tornier Insite FT Suture Anchor, Tornier, Inc. (2011) Summary page 1.
- K083268: Tornier, Inc., Insite Suture Anchors, Tornier, Inc. (2009) Summary page 1.

## Indications for use
The Tornier Insite FT Suture Anchor is intended for fixation of soft tissue to bone. The Tornier Insite FT Suture Anchor is intended for use in the following applications: 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolabral reconstruction. 2. Foot/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot Reconstruction. 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Iliotibial band tenodesis. 4. Hand/Wrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction. 5. Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction.

Source page: https://510kreport.com/device/K132632
Methodology: https://510kreport.com/methodology