# K042778: Bioanchor with Disposable Driver, Preloaded with One #2 Herculine Suture

- Pathway: 510(k) (Special)
- Applicant: Linvatec Corp.
- Decided: Nov 4, 2004 after 29 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033804 (2003). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033804: Bioanchor with Disposable Driver, Linvatec Corp. (2003) Summary page 2.

## Most influential descendants
- K123393: Healicoil Suture Anchor with Regenesorb (2013), 4 descendants of its own
- 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

## Recalls of this device
- Feb 22, 2005 · Not classified · Z-1548-05: Linvatec has determined there is a possibility the pouch Tyvek header to foil longitudinal seal was not properly sealed by Bemis Flexible Packaging, in all pouches, prior to sterilization by Linvatec.

## Indications for use
The BioAnchor® with Disposable Driver, Preloaded with One #2 HerculineTM Suture is intended for soft tissue repair of the shoulder; specifically, Bankhart and SLAP repair, capsular shifts and capsulolabral reconstruction.

Source page: https://510kreport.com/device/K042778
Methodology: https://510kreport.com/methodology