# K112849: Fixate Tissue Band

- Pathway: 510(k) (Special)
- Applicant: Anulex Technologies, Inc.
- Decided: Oct 27, 2011 after 28 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K930738 (1994). 10 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K111462: Fixate Tissue Band, Anulex Technologies, Inc. (2011)

## Most influential descendants
- K113400: Fixate Tissue Band (2011), 4 descendants of its own
- K113805: Fixate Tissue Band (2012), 3 descendants of its own
- K150924: A.I.M. Lead Loop Suturing Device (1), A.I.M. Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (1) plus Tension Assist/Suture Cutter Device, A.I.M. Lead Loop Suturing Device (2), A.I.M. Lead Loop Suturing Device plus Tension Assist/Suture Cutter Device (2015), 2 descendants of its own
- K172644: Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base (2017), 1 descendant of its own
- K191466: SandShark Injectable Anchor (SIA) System (2019), 0 descendants of its own

## Indications for use
The fiXate Tissue Band is intended to be an accessory to the leads component of Spinal Cord Stimulator systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Source page: https://510kreport.com/device/K112849
Methodology: https://510kreport.com/methodology