# K193558: HEALICOIL Knotless Suture Anchors

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Mar 18, 2020 after 86 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: 8 generations back to K961555 (1996). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073509: Twinfix PK FP Suture Anchor, Smith & Nephew, Inc. (2008) Summary page 4.
- K123393: Healicoil Suture Anchor with Regenesorb, Smith & Nephew, Inc. (2013) Summary page 4.
- K100159: Smith and Nephew Twinfix Ultra TI Suture Anchor, Smith & Nephew Inc., Endoscopy Div. (2010) Summary page 4.

## Indications for use
The Smith & Nephew HEALICOIL Knotless Suture Anchor is intended for use only for the reattachment of soft tissue to bone for the following indications: Shoulder • Biceps tenodesis • Rotator cuff tear repair

Source page: https://510kreport.com/device/K193558
Methodology: https://510kreport.com/methodology