# K983353: SCS Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Orthotec, Inc.
- Decided: Dec 18, 1998 after 86 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: 4 generations back to K901587 (1990). 15 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974749: Synergy Closed Variable Locking Screw (VLS), Part of the Cross Medical-Synergy Anterior and Posterior Spinal Systems, Cross Medical Products, Inc. (1998) Summary page 3.
- K950709: Synergy TI Anterior Spinal System, Cross Medical Products, Inc. (1995) Summary page 3.
- K950099: Synergy (TM) TI Posterior Spinal System, Buckman Co., Inc. (1997) Summary page 3.

## Most influential descendants
- K994288: 5.0MM Spinal Screws (2000), 0 descendants of its own
- K993926: Omniaxial Connector (1999), 0 descendants of its own

## Indications for use
When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic, lumbar and sacral level. When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors pseudarthrosis failed previous fusion (pseudarthrosis) The system is indicated for thoracic and lumbar level. When used as a posterior pedicle system, the device is indicated for use in skeletally mature patients who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral spine having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below. Posterior pedicle systems are intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)

Source page: https://510kreport.com/device/K983353
Methodology: https://510kreport.com/methodology