# K133777: Tornier Insite (TM) FT Peek Knotless Suture Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Apr 4, 2014 after 113 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). 53 ancestors in all.
No later device cites it as a predicate yet.
0 of 54 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.
- K110230: Rog Knotless Suture Anchor, Rog Sports Medicine, Inc. (2011)

## Indications for use
The Tomicr Insite FT PEEK Knotiass Suture Anchors are intended for fixation of soft tissnoe to bone. The Tomier Insite PT PEEK Knotless Suture Anchors are intended for use in the rollowing applications. 1. Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps Eenodesis, Acromnio-Clavicular separation and Deltoid repair, Capsular shift and Capsulolsbral reconstruction. 2. Fool/Ankle: Lateral and Medial stabilization, Achilles tendon and Metatarsal ligannent repair, Hallux Valgus and Midioot reconstruction. 3. Knee: Medial collateral and Lateral collateral ligament repair. Patchear tendon and Posterior oblique ligament repair, liliotibial band tenodesis. 4. Hand/ Wrist Scapholumate ligament, Radial collateral ligament and Ulnm collateral ligament reconstructioa. 5. Elbow Biceps tendon reatlachmenl, Tennis elbow repair, Ulnar and Radial collateral ligsament reconstruction.

Source page: https://510kreport.com/device/K133777
Methodology: https://510kreport.com/methodology