# K113805: Fixate Tissue Band

- Pathway: 510(k) (Traditional)
- Applicant: Anulex Technologies, Inc.
- Decided: Feb 23, 2012 after 62 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: 8 generations back to K930738 (1994). 12 ancestors in all.
3 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)
- K112849: Fixate Tissue Band, Anulex Technologies, Inc. (2011)
- K113400: Fixate Tissue Band, Anulex Technologies, Inc. (2011) Summary page 1.
- (no number) Ethicon, Inc., Ethibond Suture: named in the summary without a submission number

## Most influential descendants
- 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/catheter component of Spinal Cord Stimulator/Pain Pump systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Source page: https://510kreport.com/device/K113805
Methodology: https://510kreport.com/methodology