# K040594: Herculon Soft Tissue Reattachment System

- Pathway: 510(k) (Special)
- Applicant: United States Surgical, A Division of Tyco Healthc
- Decided: Mar 31, 2004 after 23 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 1 generation back to K020352 (2002). 1 ancestor in all.
8 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020352: Surgical Dynamics Ogden Suture Anchor with Suture, Unitedstates Surgical (2002) Summary page 1.

## Most influential descendants
- K071520: Renovo Suture Anchors, Models 100-2001 Thru 100-5502X (2007), 7 descendants of its own
- K101126: Pontis Sutures and Suture Anchors with Optional Crimps (2010), 3 descendants of its own
- K140127: Ferrofibre Stainless Steel Suture with Crimp (2014), 1 descendant of its own
- K090128: Tac-Tite (TM) (2009), 1 descendant of its own
- K193377: TopLock Anchor System (2020), 0 descendants of its own

## Indications for use
The Herculon* Soft Tissue Reattachment System is intended for the reapproximation of soft tissue. SHOULDER: Bankart, Slap lesion, Rotator cuff, and Deltoid repair. Acromio-clavicular separation, capsular shift/capsulolabral reconstruction and Biceps tenodesis. ELBOW: Tennis elbow repair, biceps tendon reattachment. KNEE: Extra capsular repairs; reattachment of medial and lateral collateral ligaments, posterior oblique ligament or joint capsule to tibia, and joint capsule closure to anterior proximal tibia; Extra capsular reconstruction, ITB tenodesis, Patellar ligament and tendon avulsions. ANKLE: Lateral and medial instability, Achilles tendon repair/reconstruction. PELS: Fixation in pubic bone for the purpose of bladder neck suspension.

Source page: https://510kreport.com/device/K040594
Methodology: https://510kreport.com/methodology