# K023797: Laurain Dewald Anterior Fixation System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Dec 13, 2002 after 29 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K051039: Basis Spinal System (2005), 0 descendants of its own

## Indications for use
Properly used, the LAURAIN DEWALDTMAnterior Fixation System is intended to provide stabilization during the development of a solid spinal fusion. The specific indications are: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) pseudoarthrosis, (3) spondylolysis, (4)spinal deformation such as kyphosis and lordosis, ( 5 ) fracture, (6) unsuccessful previous attempts at spinal surgery, (7) tumor resection, (8) correction of severe instability andor deformity when used in addition to a posterior spinal instrumentation system, (9) neoplastic 'disease, andor (10) deformity associated with deficient posterior elements, such as laminectomy, spina bifida, or myelomeningocele.

Source page: https://510kreport.com/device/K023797
Methodology: https://510kreport.com/methodology