# K031585: U&I, Optima, Spinal System

- Pathway: 510(k) (Special)
- Applicant: U&I Corp., America
- Decided: Jun 27, 2003 after 37 days
- Product code: MNH (Orthosis, Spondylolisthesis Spinal Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K000319 (2000). 4 ancestors in all.
579 later devices descend from it; 41 cite it directly.
0 of 584 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020279: Forex Corporation, Optima, Spinal System, Forex Corp. (2002) Summary page 1.
- K002059: Amt Spinal System, Micron Precision Engineering, Inc. (2000) Summary page 1.
- K001319: Xia Spine System Hooks, Howmedica Osteonics Corp. (2000) Summary page 1.

## Most influential descendants
- K053573: GSS Pedicle Screw System (2006), 181 descendants of its own
- K033090: Icon Polyaxial Pedicle Screw System (2004), 180 descendants of its own
- K051286: Zodiac Spinal Fixation System (2005), 176 descendants of its own
- K093077: Zodiac Polyaxial Spinal Fixation System (2009), 170 descendants of its own
- K100685: Zodiac Polyaxial Spinal Fixation System (2010), 168 descendants of its own

## Recalls of this device
- Aug 10, 2004 · Not classified · Z-1438-04: Threads on a set screw, as a component of a spinal fixation system, may break off during use.
- Jan 14, 2004 · Not classified · Z-0559-04: Reports of hex driver tips breaking off or becoming worn or stripped.
- Jan 14, 2004 · Not classified · Z-0558-04: Reports of hex driver tips breaking off or becoming worn or stripped.
- Aug 18, 2003 · Not classified · Z-1183-03: Reports of pieces chipping off the tip of screwdriver during use.
- Aug 18, 2003 · Not classified · Z-1182-03: Reports of pieces chipping off the tip of screwdriver during use.

## Indications for use
The OPTIMA posterior spinal fixation device is a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of the C5-Sl 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 OPTIMA 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). When used as an anterior screw fixation system, the OPTIMA is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, Spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Source page: https://510kreport.com/device/K031585
Methodology: https://510kreport.com/methodology