# K973868: SSCS (Segmental Spinal Correction System)

- Pathway: 510(k) (Traditional)
- Applicant: Osteotech, Inc.
- Decided: Jan 8, 1998 after 90 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
Longest line of descent: 2 generations back to K955173 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955173: SSCS (Segmental Spinal Correction System), Osteotech, Inc. (1996) Summary page 1.
- K971289: SSCS (Segmental Spinal Correction System), Osteotech, Inc. (1997) Summary page 1.
- (no number) ISOLA: named in the summary without a submission number
- (no number) TSRH: named in the summary without a submission number
- (no number) CD (Cotrel-Dubousset): named in the summary without a submission number
- (no number) USS: 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 - previously failed attempts at spinal fusion 2) When used as a sacral/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. d. Who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint, the SSCS screws may be inserted into pedicles up to, but not above, L-3.

Source page: https://510kreport.com/device/K973868
Methodology: https://510kreport.com/methodology