# K083077: Ulc Spinal Pedicle Screw System

- Pathway: 510(k) (Traditional)
- Applicant: Otis Biotech Co., Ltd.
- Decided: Oct 26, 2009 after 375 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal 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: 4 generations back to K000319 (2000). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072436: Mega Spine System, Bk Meditech, Co., Ltd. (2007) Summary page 1.
- K071857: Delta Spinal Fusion System, Jemo Spine, LLC (2007) Summary page 1.
- K053115: Xia Spinal System, Stryker Spine (2005) Summary page 1.
- K051971: Optima Spinal System, U&I Corp. (2005) Summary page 2.

## Indications for use
The ULC spinal pedicle screw systems are intended for posterior and non-cervical pedicle fixation for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion 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. In addition, the ULC 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 Spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis).

Source page: https://510kreport.com/device/K083077
Methodology: https://510kreport.com/methodology