# K092371: Swift-Lock Anchor, Model 1192

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Neuromodulation Systems
- Decided: Dec 23, 2009 after 140 days
- Product code: GZB (Stimulator, Spinal-Cord, Implanted (Pain Relief))
- Device class: 2
- Regulation: 21 CFR 882.5880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite it directly.
0 of 9 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 no predicate by number.

## Most influential descendants
- K111462: Fixate Tissue Band (2011), 6 descendants of its own
- K112849: Fixate Tissue Band (2011), 5 descendants of its own
- 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

## Recalls of this device
- Feb 22, 2010 · Not classified · Z-1425-2010: Directions For Use of product incorrectly stated lead compatibility information.

## Indications for use
ANS Neurostimulation Systems are indicated for spinal cord stimulation (SCS) in the management of chronic pain of the trunk and limbs, either as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Swift-LockTM anchor is intended to be an accessory to the leads component of ANS SCS systems functioning to secure the lead to the fascia or inter-spinous/supra-spinous ligament.

Source page: https://510kreport.com/device/K092371
Methodology: https://510kreport.com/methodology