# K110773: Tornier Insite FT Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jun 2, 2011 after 73 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: 6 generations back to K921873 (1992). 38 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083268: Tornier, Inc., Insite Suture Anchors, Tornier, Inc. (2009) Summary page 2.
- K091870: Tornier, Piton Fixation Implant System, Tornier (2009) Summary page 2.
- K071586: Bioraptor 2.3 PK Suture Anchor, Smith & Nephew Inc., Endoscopy Division (2007) Summary page 2.

## Most influential descendants
- 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
- K132632: Tornier Insite FT Suture Anchor with Needles (2013), 0 descendants of its own

## Indications for use
The Tornier InsitTM FT Suture Anchors are intended for fixation of soft tissue to bone. The Tornier InsiteTm FT Suture Anchors are 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, H-allux Valgus and Midfoot Reconstruction. 3. Knee: Medial collateral and Lateral collateral ligament repair, Patellar tendon and Posterior oblique ligament repair, Illiotibial 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/K110773
Methodology: https://510kreport.com/methodology
