510(k) · Cleared
Recalled · 2004Forex Corporation, Optima, Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Forex Corp. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jun 20, 2002 as substantially equivalent to K002059 (Micron Precision Engineering, Inc., 2000) and 1 other predicate after a 143-day review. Its family tree reaches back 1 generation to 2000. 693 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 20, 2002
- Review
- 143 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 4
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000319 (2000). 2 ancestors in all. 693 later devices descend from it, 9 citing it directly.
- Root · 1 generation backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- This deviceK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002
- Descendant · cites it directly · 579 of its ownK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- Descendant · cites it directly · 466 of its ownK024096 Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- Descendant · 2 generations on · 181 of its ownK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- Descendant · 2 generations on · 180 of its ownK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- Descendant · cites it directly · 178 of its ownK070933 Lowtop Pedicle Screw SystemSanacor · 2007
Showing 5 of 693 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 693 · See all- K031585U&I, Optima, Spinal SystemU&I Corp., America · 2003 · cites it directly579descendants
- K024096Optima, Spinal SystemU&I Corp., America · 2003 · cites it directly466descendants
- K053573GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006 · 2 generations on181descendants
- K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · 2 generations on180descendants
- K070933Lowtop Pedicle Screw SystemSanacor · 2007 · cites it directly178descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| 0 (this device) | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | — |
| +1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| +1 | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | 3 |
| +2 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| +2 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| +1 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 12 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 19 | 0 |
| 2011 | 16 | 0 |
| 2012 | 26 | 0 |
| 2013 | 37 | 0 |
| 2014 | 37 | 0 |
| 2015 | 42 | 0 |
| 2016 | 40 | 0 |
| 2017 | 40 | 0 |
| 2018 | 45 | 0 |
| 2019 | 28 | 0 |
| 2020 | 38 | 0 |
| 2021 | 33 | 0 |
| 2022 | 41 | 0 |
| 2023 | 56 | 0 |
| 2024 | 49 | 0 |
| 2025 | 44 | 0 |
| 2026 | 46 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002059 | Amt Spinal SystemSummary page 1…per 21 CFR 5 888.3060 Substantially Eauivalent Predicate tecrally Marketed Devices: Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) StrykerO Spine,XiaTMSpinal System -- MNH,MNI, KWQ -- (K00q319) The substantial equivalence of this device is based… | 2000 |
| * | K000319 | Ebi Xfix DFS System | 2000 |
What descends from it? (693)
See all 6939 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031585 | U&I, Optima, Spinal System | 2003 | 579 |
| K024096 | Optima, Spinal System | 2003 | 466 |
| K070933 | Lowtop Pedicle Screw System | 2007 | 178 |
| K071857 | Delta Spinal Fusion System | 2007 | 109 |
| K093104 | Medyssey CO., LTD., Zenius Spinal System | 2010 | 20 |
| K151704 | Diplomat® Spinal System | 2016 | 4 |
| K141282 | PGS 5.5 MM Cannulated Pedicle Screw | 2014 | 1 |
| K071879 | Zimmer Dto Implant | 2007 | 1 |
| K143230 | Palladian Lumbar Pedicle Screw System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 10, 2004 | Not classified | Z-1438-04 | Other | 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 | Other | Reports of hex driver tips breaking off or becoming worn or stripped. |
| Jan 14, 2004 | Not classified | Z-0558-04 | Other | Reports of hex driver tips breaking off or becoming worn or stripped. |
| Aug 18, 2003 | Not classified | Z-1182-03 | Other | Reports of pieces chipping off the tip of screwdriver during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (190 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020279: Forex Corporation, Optima, Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020279
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026