# K030087: Spinal Concepts, Inc. Bacfix TI Spinal System

- Pathway: 510(k) (Abbreviated)
- Applicant: Spinal Concepts, Inc.
- Decided: Jul 17, 2003 after 189 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- 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
Longest line of descent: 3 generations back to K980447 (1998). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013887: Bacfix Spinal Fixation System, Spinal Concepts, Inc. (2002)
- K021564: Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002)
- K023644: Modification to Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002) Summary page 1.
- K022605: Blackstone Spinal Fixation System Staple & Washer, Blackstone Medical, Inc. (2002) Summary page 1.
- K953925: Fine Grain Cast Cobalt Chromium Hip Stems, Biomet, Inc. (1996) Summary page 1.
- K000450: Modification to Synthes Uss, Synthes Spine (2000) Summary page 1.
- K001066: CD Horizon Eclipse, Medtronic Sofamor Danek, Inc. (2000) Summary page 1.
- K982990: TSRH Spinal System, Sofamor Danek USA,Inc. (1998) Summary page 1.

## Indications for use
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 disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), 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. When intended for anterolateral screw, rod and or cable fixation of the T6L5 spine the indications are degenerative disc disease (back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (Le. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. 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 these indications range from L3 to the sacrum. When intended for non-pedicle, posterior screw fixation of the non-cervical spine, the indications are: Idiopathic scoliosis. Neuromuscular scoliosiskyphoscoliosis 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/K030087
Methodology: https://510kreport.com/methodology