# K032739: Ucr Spinal System

- Pathway: 510(k) (Special)
- Applicant: Seaspine
- Decided: Nov 20, 2003 after 77 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
Longest line of descent: 6 generations back to K901587 (1990). 18 ancestors in all.
174 later devices descend from it; 6 cite it directly.
0 of 193 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993503: Haider-Ucr Spinal System, International Advanced Medical Enterprises, Inc. (2000) Summary page 1.
- K021623: Ucr Spinal System, 5.5MM, 8.0MM Screws & Instruments, Iame, Inc. (2002) Summary page 1.
- K031381: Ucr Spinal System, Laminar Hooks, Pedicle Hooks, and Instruments, Seaspine (2003) Summary page 1.

## Most influential descendants
- 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
- K132049: Thunderbolt and Lancer  Pedicle Screw Systems (2014), 82 descendants of its own

## Indications for use
The intended use of the UCR Spinal System variable and fixed cross links remains the same as that of the existing variable and fixed cross links. 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 neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudoarthrosis).

Source page: https://510kreport.com/device/K032739
Methodology: https://510kreport.com/methodology