# K083268: Tornier, Inc., Insite Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Tornier, Inc.
- Decided: Feb 12, 2009 after 99 days
- Product code: MAI (Fastener, Fixation, Biodegradable, Soft Tissue)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K003227 (2001). 13 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003971: Axya Medical, Inc. Model 1000 Axyaloop Bone Anchor, Axya Medical, Inc. (2001) Summary page 1.
- K011912: Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000, Axya Medical, Inc. (2001) Summary page 1.
- K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor, Axya Medical, Inc. (2005) Summary page 1.
- K051983: Model 3000 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2005) Summary page 1.
- K041698: Axya Medical, Inc. Model 5000 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2004) Summary page 1.
- K060970: Axyaloop Nonabsorbable Bone Anchor, Axya Medical, Inc. (2006) Summary page 1.

## Cited in the summary but kept off the family tree
- K051250: Axya, Model 6500 Axyaloop Bio-Absorbable Bone Anchor, Axya Medical, Inc. (2005). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## 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
Tornier(D Insite TM Suture Anchors are intended for use. for the reattachment of soft tissue to bone for the following indications: Shoulder: Rotator Cuff, Bankart and SLAP lesion repair, Biceps tenodesis, Acromio-Clavicular separation and Deltoid repair, Capsular shift and Capsulabral reconstruction Foot/Ankle: Lateral and Medial-stabilization, Achilles tendon and Metatarsal ligament repair, Hallux Valgus and Midfoot reconstruction Knee: Medial collateral and Lateral collateral ligament repair, Pateliar tendon and Posterior oblique ligament repair, lliotibial band tenodesis HandNWrist: Scapholunate ligament, Radial collateral ligament and Ulnar collateral ligament reconstruction Elbow: Biceps tendon reattachment, Tennis elbow repair, Ulnar and Radial collateral ligament reconstruction P'elvis: Bladder neck suspension for urinary incontinence due to urethral ·hypermobilitY or intrinsic sphincter deficiency infemales

Source page: https://510kreport.com/device/K083268
Methodology: https://510kreport.com/methodology