# K051971: Optima Spinal System

- Pathway: 510(k) (Special)
- Applicant: U&I Corp.
- Decided: Aug 4, 2005 after 14 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
387 later devices descend from it; 18 cite it directly.
0 of 388 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 no predicate by number.

## Most influential descendants
- K062513: Apex Spine System (2006), 179 descendants of its own
- K092825: Apex Spine System 5.50 MM Titanium Rod & Polyaxial Screw Washer (2010), 178 descendants of its own
- K102488: Apex Spine System W/ Cocr Rods (2010), 177 descendants of its own
- K120291: OP Spine System (2012), 138 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own

## Indications for use
The OPTIMATM posterior spinal fixation device is a pedicle screw system indicated 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 OPTIMATM 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 OPTIMATM 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 such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts. In case of spinal deformities, OPTIMATM may be used with posterior hook.

Source page: https://510kreport.com/device/K051971
Methodology: https://510kreport.com/methodology