# K991586: SSCS (Segmental Spinal Correction System)

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Jul 23, 1999 after 77 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.
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. The FDA summary names its predicate without a number.
- (no number) SSCS: named in the summary without a submission number
- (no number) ISOLA: named in the summary without a submission number
- (no number) TSRH: named in the summary without a submission number

## Indications for use
The SSCS is intended for use as a posterior spinal fixation device, with specific indications as follows: 1) When used as a thoracic/lumbar hook or sacral screw and hook system, the SSCS is intended for instrumentation of the spine at levels ranging from T1 to S2 and is indicated for: scoliosis; kyphosis; spinal fractures; degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); tumors; stenosis; spondylolisthesis; pseudoarthrosis; and previously failed attempts at spinal fusion. 2) When used as a pedicle screw system in the thoraco-lumbo-sacral region of the spine, the SSCS is indicated for degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). 3) In addition, when used as a pedicle screw system, the SSCS is intended for patients: a. Having severe spondylolisthesis (grade 3 or 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint b. Who are receiving fusions using autogenous bone graft only. c. Who are having the device fixed or attached to the lumbar and sacral spine (level of attachment: L3 and below). d. Who are having the device removed after the development of a solid fusion mass.

Source page: https://510kreport.com/device/K991586
Methodology: https://510kreport.com/methodology