# K031381: Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Seaspine
- Decided: Jul 30, 2003 after 90 days
- Product code: MNI (Orthosis, Spinal Pedicle 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.
175 later devices descend from it; 4 cite it directly.
0 of 176 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) Synergy Posterior Spinal System: named in the summary without a submission number
- (no number) CD Horizon: named in the summary without a submission number

## Most influential descendants
- K032739: Ucr Spinal System (2003), 174 descendants of its own
- K043232: Ucr Spinal System (2004), 97 descendants of its own
- K081331: Fixxsure Cross Link (2008), 91 descendants of its own
- K110692: Streamline TL Spinal System (2011), 89 descendants of its own
- K111502: Streamline TL Spinal System (2011), 88 descendants of its own

## Indications for use
The intended use of the UCR Spinal System hooks and their components is substantially equivalent to the intended use of the predicate devices. The intended use of the UCR Spinal System and hooks is as a temporary or permanent posterior implant to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur. The intended use and indications when used as a Spondylolisthesis Spinal Fixation Device System are: The UCR Spinal System is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. The intended use and indications when used as a Pedicle Screw Spinal System are: The UCR Spinal System is a pedicle screw system 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 spondylolisthesis with objective evidence of impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis). Hook Spinal System indications are limited to T1-L5 and are: degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history ad radiographic), spinal stenosis, spondylolisthesis, spinal deformities (scoliosis, kyphosis, and/or lordosis), fracture, pseudarthosis, tumor resection, and/or failed previous fusion.

Source page: https://510kreport.com/device/K031381
Methodology: https://510kreport.com/methodology