# K024096: Optima, Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: U&I Corp., America
- Decided: Mar 12, 2003 after 90 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 3 (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.
466 later devices descend from it; 30 cite it directly.
0 of 471 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
- K091725: Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) (2009), 150 descendants of its own
- K120291: OP Spine System (2012), 138 descendants of its own
- K121630: Range Spinal System (2012), 127 descendants of its own
- K103085: Venus Basic Spinal Fixation System (2011), 123 descendants of its own
- K120270: Venus Spinal Fixation System (2012), 111 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.

## Indications for use
The OPT/MATM 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 OPT/MATM 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/K024096
Methodology: https://510kreport.com/methodology