# K974757: Kaneda Anterior Scoliosis System Kass

- Pathway: 510(k) (Traditional)
- Applicant: Acromed Corp.
- Decided: Mar 5, 1998 after 76 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.
607 later devices descend from it; 7 cite it directly.
1 of 608 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Kaneda SR Anterior Spinal System: named in the summary without a submission number

## Most influential descendants
- K012916: Frontier Anterior Scoliosis System (2001), 601 descendants of its own
- K071668: Orthobiom Spinal System (2008), 582 descendants of its own
- K091445: CD Horizon Spinal System (2010), 581 descendants of its own
- K110070: TSRH Spinal System (2011), 269 descendants of its own
- K111457: CD Horizon Spinal System (2011), 261 descendants of its own

## Indications for use
The Kaneda Anterior Scoliosis System is intended for use in: 1. Idiopathic scoliosis. 2. Degenerative Disc Disease defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. 4. Neuromuscular scoliosis/Kyphoscoliosis 5. Spinal fractures (acute reduction or late deformity). 6. Revision surgery. 7. Tumor. In addition, the Kaneda Anterior Scoliosis System can also be used for the correction and stabilization of scoliotic curves, for the prevention or recurrence of undesired scoliotic curves, and for the stabilization of weakened trunks. Indications for these scoliotic uses include: 1. Collapsing and unstable paralytic deformity. 2. Progressively increasing scoliosis. 3. Decreasing cardio-respiratory function, secondary to spinal or rib deformity or collapse. 4. Inability to maintain sitting balance, necessitating the use of hands. 5. Increasing pelvic obliquity coincident with back pain or loss of sitting balance. The intended levels for treatment with the Kaneda Anterior Scoliosis System, are T4 to L4.

Source page: https://510kreport.com/device/K974757
Methodology: https://510kreport.com/methodology