# K973687: Spinal Concepts, Inc., Bacfix TI Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Mar 18, 1998 after 173 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- 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) BacFix™ Spinal Fixation System: named in the summary without a submission number
- (no number) Synthes Universal Spinal System: named in the summary without a submission number

## 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 (T1-S1). When intended for pedicle screw fixation, the implants are intended for use in Grade 3 and 4 sponylolisthesis at L5-S1, utilizing autologous bone graft, having the device fixed or attached to the lumbar and sacral spine and intended to be removed after solid fusion is attained. Levels of pedicle screw attachment for this indication range from L3 to the sacrum. When intended for non-pedicle, posterior screw fixation, the system is intended for hook and/or sacral/iliac screw fixation from the thoracic spine to the ileum/sacrum. The indications are: Idiopathic scoliosis. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spacticity. Scoliosis with deficient posterior elements such as that resulting from laminectomy or myelomeningocele. Spinal fractures (acute reduction or late deformity). Degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). Neoplastic disease. Spondylolisthesis. Spinal stenosis. Revision surgery.

Source page: https://510kreport.com/device/K973687
Methodology: https://510kreport.com/methodology