# K123393: Healicoil Suture Anchor with Regenesorb

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 11, 2013 after 160 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: 7 generations back to K961555 (1996). 19 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113294: Smith & Nephew Healicoil PK Suture Anchor, Smith & Nephew, Inc. (2012)
- K101459: Osteoraptor II Suture Anchor or to BE Determined Model: 72202764 72202765 72202766 72202767 72202768 72202769 72202770, Smith & Nephew, Inc. (2011) Summary page 1.
- K032197: Twin Fix AB 6.5 MM Suture Anchor, Models 720209, 7210210, 7210211, 7210212, Smith & Nephew, Inc. (2003) Summary page 1.
- K070925: Modification to: Bioknotless BR Anchor / Lupine BR Anchor, Depuy Mitek, A Johnson & Johnson Company (2007) Summary page 1.
- K042778: Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture, Linvatec Corp. (2004) Summary page 1.

## Most influential descendants
- K151105: Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa (2015), 1 descendant of its own
- K193558: HEALICOIL Knotless Suture Anchors (2020), 0 descendants of its own
- K163672: Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor (2017), 0 descendants of its own
- K142948: BIOSURE REGENESORB interference Screw (2015), 0 descendants of its own

## Indications for use
The Smith & Nephew HEIALICOIL Absorbable Suture Anchor is intended for the reattachment of soft tissue to bone for the following indications: Shculder: Bankart lesion repairs Slap lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis Knee: Extra-capsular repairs: Medial collateral ligament Lateral collateral ligament Posterior oblique ligament Patellar realignment and tendon repairs: Vastus medialis obliquous advancement Iliotibial band tenodesis. Foot & Ankle: Hallux valgus repairs Medial or lateral instability repairs/reconstructions Achilles tendon repairs/reconstruction Midfoot reconstructions Metatarsal ligament/tendon repairs/reconstructions Elbow: Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Source page: https://510kreport.com/device/K123393
Methodology: https://510kreport.com/methodology