# K041069: Spiralok 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: 16 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021883 (2002). 1 ancestor in all.
100 later devices descend from it; 1 cites it directly.
0 of 102 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021883: Biofastin RC Threaded Suture Anchor, Mitek Worldwide (2002) Summary page 2.

## Most influential descendants
- 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
- K090124: Gryphon P BR DS Anchor W/Orthocord,Gryphon P BR Anchor W/Orthocord, Model 210813,210814 (2009), 25 descendants of its own

## Recalls of this device
- Sep 6, 2012 · Class II · Z-0140-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0152-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0143-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0145-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0146-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0148-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0149-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0142-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0151-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0154-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0141-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0144-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0147-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0150-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0153-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision
- Sep 6, 2012 · Class II · Z-0155-2013: Fracture of SPIRALOK Anchors post op, requiring patient revision

## Indications for use
The Spiralok Anchor is intended for: Shoulder: Rotator cuff repair.

Source page: https://510kreport.com/device/K041069
Methodology: https://510kreport.com/methodology