# K201636: Hercules Suture Anchor System

- Pathway: 510(k) (Traditional)
- Applicant: In2bones USA, LLC
- Decided: Aug 20, 2020 after 65 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: 8 generations back to K921873 (1992). 54 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 56 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 5.
- K150715: 2.5mm Insite FT Suture Anchors , 3.5mm Insite FT Suture Anchors, Tornier, Inc. (2015) Summary page 5.
- K112237: Microsuture Anchors, Arthrex, Inc. (2011) Summary page 5.
- K071257: Mini Quickanchor and Quickanchor Plus with Orthocord, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 5.
- K992487: Mitek Mini Quickanchor Plus, Mitek Products (1999) Summary page 5.

## Most influential descendants
- K253538: TeKBrace Knotless Anchor (2026), 0 descendants of its own

## Indications for use
The In2Bones Hercules™ 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. 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/K201636
Methodology: https://510kreport.com/methodology