# K043411: Resofix Bioabsorbable Expansion Bolt

- Pathway: 510(k) (Traditional)
- Applicant: Resofix, Inc.
- Decided: Feb 17, 2005 after 69 days
- Product code: HTN (Washer, Bolt Nut)
- 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
No predicates in its family tree.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Arthrex Bio-Interference Screw: named in the summary without a submission number

## Most influential descendants
- K060494: Easytac Anchor.  Easytac Delivery System (2006), 14 descendants of its own
- K082396: Davol Absorbable Fastener System, Model (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 (2009), 13 descendants of its own
- K092483: Bard Permafix Fixation System, Model 0113012, 0113014, 0113016, 0116018 (2009), 6 descendants of its own
- K132134: Optifix Absorbable Fixation System (2013), 4 descendants of its own
- K142873: OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners (2015), 3 descendants of its own

## Indications for use
The Resofix® Bioabsorbable Expansion Bolt is a single-use, sterile implant that is intended for use in the interference fixation of bone-tendon-bone and soft tissue grafts in anterior and posterior cruciate ligament reconstruction.

Source page: https://510kreport.com/device/K043411
Methodology: https://510kreport.com/methodology