# K023644: Modification to Incompass Spinal Fixation System

- Pathway: 510(k) (Special)
- Applicant: Spinal Concepts, Inc.
- Decided: Nov 25, 2002 after 26 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
Longest line of descent: 1 generation back to K021564 (2002). 1 ancestor in all.
122 later devices descend from it; 5 cite it directly.
0 of 124 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021564: Incompass Spinal Fixation System, Spinal Concepts, Inc. (2002)

## Most influential descendants
- K030625: Spinal Concepts Inc. Pathfinder (2003), 109 descendants of its own
- K071174: Pathfinder System Polyaxial Pedicle Screws (2007), 94 descendants of its own
- K113044: Synthes Mirs (2011), 93 descendants of its own
- K120571: Synthes Uss Connector (2012), 74 descendants of its own
- K133746: Polaris Spinal System (2014), 67 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 TI-SI, 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, andor lordosis), tumor and failed previous fusion. As a pedicle screw system placed between L3 and SI, 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 (TI-Sl), 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, andor 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/K023644
Methodology: https://510kreport.com/methodology