# K992012: Wiltse System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Spine Fixation Systems, Inc.
- Decided: Feb 4, 2000 after 234 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Wiltse System [s a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1.vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The Wiltse System is also intended for anterolateral screw fixation of the noncervical spine. Indications for this system include treatment of cases of spondylolisthesis, fracture, spinal stenosis, deformities (including scoliosis, kyphosis, and lordosls), tumor, pseudoarthrosis, and fevision of failed previous fusion surgery. Other indications include degenerative lumbar scoliosis, degenerative spondylolisthesis, and in spinal stenosis, where decompression is required. The Wiltse System |s intended for use by the orthopedic surgeon specializing in spinal surgery. Advanced Spine Fixation Systems Incorporated personnel are available to provide speclalized training for surgeons in the use ot the device. The attachment points of the sacral screws are intended for the S1 or S2 locations. The sublaminar wire fixation levels range from L1 to L5,

Source page: https://510kreport.com/device/K992012
Methodology: https://510kreport.com/methodology