# K021883: Biofastin RC Threaded Suture Anchor

- Pathway: 510(k) (Special)
- Applicant: Mitek Worldwide
- Decided: Jul 1, 2002 after 24 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
No predicates in its family tree.
116 later devices descend from it; 3 cite it directly.
0 of 117 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) FASTIN RC Suture Anchor: named in the summary without a submission number
- (no number) Mitek Cuff Tack Sutureless Fixation Device: named in the summary without a submission number
- (no number) PANALOK RC Absorbable Anchor: named in the summary without a submission number

## Most influential descendants
- K041069: Spiralok Anchor (2004), 100 descendants of its own
- K071481: Healix Anchor (2007), 99 descendants of its own
- K120449: Healix Advance Peek Anchor (2012), 50 descendants of its own
- K073412: Gryphon BR and Healix BR Anchors (2008), 44 descendants of its own
- K133636: Extremity Medical Hammertoe Device (2014), 31 descendants of its own

## Indications for use
The BIOFASTIN RC Threaded Suture Anchor is indicated for shoulder rotator cuff repair.

Source page: https://510kreport.com/device/K021883
Methodology: https://510kreport.com/methodology