# K983818: Mitek Fastin RC Anchor

- Pathway: 510(k) (Special)
- Applicant: Mitek Products
- Decided: Nov 23, 1998 after 25 days
- Product code: MBI (Fastener, Fixation, Nondegradable, Soft Tissue)
- 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.
34 later devices descend from it; 2 cite it directly.
0 of 35 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) Mitek FASTIN® Anchor: named in the summary without a submission number

## Most influential descendants
- K041075: Fastin RC Anchor (2004), 22 descendants of its own
- K082282: Healix TI Anchor (2008), 21 descendants of its own
- K102298: Transtend BR Anchor W/ Orthocord, Transtend TI Anchor W/Orthocord, Transtend Peek Anchor W/Orthocord, Healix Transtend (2011), 15 descendants of its own
- K011912: Model 2000 Axyaloop Self-Tapping Bone Anchor, Model 2000 (2001), 10 descendants of its own
- K052491: Axya Model 6500 Axyaloop Self-Tapping Bone Anchor (2005), 9 descendants of its own

## Indications for use
Rotator cuff repair

Source page: https://510kreport.com/device/K983818
Methodology: https://510kreport.com/methodology