# K041075: Fastin RC Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Mitek, A Johnson & Johnson Company
- Decided: Nov 9, 2004 after 197 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 K983818 (1998). 1 ancestor in all.
22 later devices descend from it; 1 cites 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)
- K983818: Mitek Fastin RC Anchor, Mitek Products (1998) Summary page 2.

## Most influential descendants
- 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
- K211002: Grappler Suture Anchor System (2021), 6 descendants of its own
- K103712: Gryphon Peek DS Anchor W/ Orthocord, Gryphon Peek Anchor W/ Orthocord (2011), 6 descendants of its own
- K222091: Grappler Suture Anchor System (2022), 3 descendants of its own

## Recalls of this device
- Oct 27, 2005 · Not classified · Z-0446-06: The device may contain one strand of suture instead of two strands

## Indications for use
The Fastin RC Anchors are intended for: Shoulder: Rotator cuff repair.

Source page: https://510kreport.com/device/K041075
Methodology: https://510kreport.com/methodology