# K020279: Forex Corporation, Optima, Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Forex Corp.
- Decided: Jun 20, 2002 after 143 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000319 (2000). 2 ancestors in all.
693 later devices descend from it; 9 cite it directly.
0 of 696 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002059: Amt Spinal System, Micron Precision Engineering, Inc. (2000) Summary page 1.
- K000319: Ebi Xfix DFS System, Ebi, L.P. (2000)

## Most influential descendants
- K031585: U&I, Optima, Spinal System (2003), 579 descendants of its own
- K024096: Optima, Spinal System (2003), 466 descendants of its own
- K053573: GSS Pedicle Screw System (2006), 181 descendants of its own
- K033090: Icon Polyaxial Pedicle Screw System (2004), 180 descendants of its own
- K070933: Lowtop Pedicle Screw System (2007), 178 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-1182-03: Reports of pieces chipping off the tip of screwdriver during use.

## Indications for use
The FOREX Corporation, OPTIMA 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 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 or a posterior hook and sacral/iliac 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/K020279
Methodology: https://510kreport.com/methodology