# K013887: Bacfix Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Feb 12, 2002 after 81 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices 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) Isola Spinal System: named in the summary without a submission number

## Most influential descendants
- K031354: Ebi OMEGA21 Spinal Fixation System (2003), 13 descendants of its own
- K082353: Mercury Spinal System (2009), 11 descendants of its own
- K083230: Mercury Spinal System (2008), 11 descendants of its own
- K091587: Mercury Spinal System (2009), 10 descendants of its own
- K141372: Mercury Spinal System (2014), 9 descendants of its own

## Indications for use
The SCI BacFix® Ti Spinal Fixation System consists of a combination of components which include rods, hooks, locking wedges, screws, transverse connectors, cable-screws, cables and spinous process grommets which are indicated to provide temporary stability of the thoracic, thoracolumbar, or lumbar spine (T1 to 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 or sacral spine: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). Levels of pedicle screw attachment for these indications range to T1 to the sacrum. As a pedicle screw system, the BacFix® Spinal Fixation System is also intended for patients having Grade 3 or Grade 4 spondylolisthesis at L5-S1, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. Levels of pedicle screw fixation for this indication are from L3 to the sacrum. When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are: Idiopathic scoliosis. Neuromuscular scoliosis/kyphoscoliosis with associated paralysis or spasticity. 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. Failed previous fusion. The cable-screws, cables and spinous process grommets are indicated for: Defect of pars lateralis. Spondylolisthesis. Cables and spinous processes grommets may be used for interspinous wiring if additional stability is needed.

Source page: https://510kreport.com/device/K013887
Methodology: https://510kreport.com/methodology