# K021564: Incompass Spinal Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Spinal Concepts, Inc.
- Decided: Oct 25, 2002 after 165 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- 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.
201 later devices descend from it; 7 cite it directly.
0 of 202 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) BacFix Spinal Fixation System: named in the summary without a submission number

## Most influential descendants
- K091717: Any Plus Spinal Fixation System (2010), 130 descendants of its own
- K023644: Modification to Incompass Spinal Fixation System (2002), 122 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 descendants of its own
- K030625: Spinal Concepts Inc. Pathfinder (2003), 109 descendants of its own
- K071174: Pathfinder System Polyaxial Pedicle Screws (2007), 94 descendants of its own

## Recalls of this device
- Mar 24, 2008 · Not classified · Z-1592-2008: Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

## Indications for use
When intended for pedicle screw fixation from T1-S1, the Incompass Spinal Fixation System is 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, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion. As a pedicle screw system placed between L3 and S1, the indications include Grade 3 or Grade 4 spondylolisthesis, when utilizing autologous bone graft, when affixed to the posterior lumbosacral spine, and intended to be removed after solid fusion is established. When intended for non-pedicle, posterior screw fixation of the non-cervical spine (T1-S1), 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), tumor, spondylolisthesis, spinal stenosis and failed previous fusion. When intended for anterolateral screw, rod and or cable fixation of the T6-L5 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 (i.e. fracture or dislocation), spinal stenosis, deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor and failed previous fusion The use of posterior spinal instrumentation in children has been reported in the literature. The Incompass Spinal Fixation System may be used for non-pedicle posterior use in this patient group. After solid fusion occurs, these devices serve no functional purpose and should be removed. In most cases, removal is indicated because the implants are not intended to transfer or support forces developed during normal activities. Any decision to remove the device must be made by the physician and the patient, taking into consideration the patient's general medical condition and the potential risk to the patient of a second surgical procedure.

Source page: https://510kreport.com/device/K021564
Methodology: https://510kreport.com/methodology