# K150715: 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Jul 28, 2015 after 131 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). 42 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 45 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 4.
- K081511: 2.0 PK Suture Anchor T, 2.0 PK Suture Anchor S, Smith & Nephew, Inc. (2008) Summary page 4.

## Most influential descendants
- K201636: Hercules Suture Anchor System (2020), 1 descendant of its own
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants of its own

## Indications for use
The 2.5mm and 3.5mm Insite™ FT PEEK Suture Anchor is intended for total shoulder arthroplasty of the shoulder. The Tornier Insite™ FT PEEK Suture Anchors are intended for fixation of soft tissue to bone. The Tornier Insite™ FT PEEK 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, Hallux 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/K150715
Methodology: https://510kreport.com/methodology