# K983258: Modification to Spinal Concepts Bacfix Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Oct 21, 1998 after 35 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- 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) Zimmer Modulock Posterior Spinal System: named in the summary without a submission number
- (no number) Sofamor Danek TSRH Spinal System: named in the summary without a submission number

## Recalls of this device
- Apr 1, 2002 · Not classified · Z-0922-04: The instrument can break during surgery causing delay of surgery and/or fragments in the surgical site.

## Indications for use
The Spinal Concepts, Inc. BacFix™ Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws and transverse connectors which are indicated to provide temporary stability of the thoracic, thoracolumbar or lumbar spine (11-S1). When intended for pedicle screw fixation, implants 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 and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range from T1 to the sacrum, In addition, when intended for pedicle screw fixation, implants are intended for treatment of severe spondylolisthesis (grades 3 and 4) of the vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of implants after the attainment of solid fusion. The levels of screw fixation for these indications range from L3 to the sacrum. When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indicationg are: 1. Idiopathic scohosis. 2. Neuromuscular scoliosis’kyphoscolios:s with associated paralysis or spacticity. 3. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. 4. Spinal fractures (acute reduction or late deformity). 5. Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studics). Neoplastic discase. Spondylolisthesis. Spinal stenosis. Failed previous fusion.

Source page: https://510kreport.com/device/K983258
Methodology: https://510kreport.com/methodology