510(k) · Cleared
Recalled · 2004U&I, Optima, Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corp., America · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 27, 2003 as substantially equivalent to K020279 (Forex Corp., 2002) and 2 other predicates after a 37-day review. Its family tree reaches back 2 generations to 2000. 579 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 27, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- MNH
- Recalls
- 5
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000319 (2000). 4 ancestors in all. 579 later devices descend from it, 41 citing it directly.
- Root · 2 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 1 generation backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- This deviceK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003
- Descendant · cites it directly · 181 of its ownK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- Descendant · cites it directly · 180 of its ownK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- Descendant · 2 generations on · 176 of its ownK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- Descendant · 2 generations on · 170 of its ownK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- Descendant · 2 generations on · 168 of its ownK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
Showing 5 of 579 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 579 · See all- K053573GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006 · cites it directly181descendants
- K033090Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · cites it directly180descendants
- K051286Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005 · 2 generations on176descendants
- K093077Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009 · 2 generations on170descendants
- K100685Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010 · 2 generations on168descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −1 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| 0 (this device) | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | — |
| +1 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| +1 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| +2 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| +2 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| +2 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 7 | 0 |
| 2008 | 13 | 0 |
| 2009 | 9 | 0 |
| 2010 | 10 | 0 |
| 2011 | 9 | 0 |
| 2012 | 22 | 0 |
| 2013 | 24 | 0 |
| 2014 | 33 | 0 |
| 2015 | 33 | 0 |
| 2016 | 33 | 0 |
| 2017 | 36 | 0 |
| 2018 | 37 | 0 |
| 2019 | 25 | 0 |
| 2020 | 34 | 0 |
| 2021 | 28 | 0 |
| 2022 | 36 | 0 |
| 2023 | 52 | 0 |
| 2024 | 47 | 0 |
| 2025 | 39 | 0 |
| 2026 | 43 | 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 MNH? 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? (3)
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 |
|---|---|---|---|
| * | K020279 | Forex Corporation, Optima, Spinal SystemSummary page 1…PTIMATM,Spinal System is substantially equivalent in function, design, composition, labeling, and intended use to: OPTIMArM,Spinal System MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryket-0 Spine, XiaTMSpinal System -- MN… | 2002 |
| * | K002059 | Amt Spinal SystemSummary page 1…mposition, labeling, and intended use to: OPTIMArM,Spinal System MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryket-0 Spine, XiaTMSpinal System -- MNH, MNI, KWQ - (K001319) The substantial equivalence of this device is ba… | 2000 |
| * | K001319 | Xia Spine System HooksSummary page 1…MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Stryket-0 Spine, XiaTMSpinal System -- MNH, MNI, KWQ - (K001319) The substantial equivalence of this device is based on equivalence in intended use, materials, designs and operat… | 2000 |
What descends from it? (579)
See all 57941 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053573 | GSS Pedicle Screw System | 2006 | 181 |
| K033090 | Icon Polyaxial Pedicle Screw System | 2004 | 180 |
| K060702 | 4CIS Vane Spine System | 2006 | 166 |
| K120291 | OP Spine System | 2012 | 138 |
| K081145 | Modification to 4CIS Vane Spine System | 2008 | 127 |
| K050471 | 4CIS Solar Spine System and 4CIS Apollon Spine System | 2005 | 127 |
| K043578 | The 4CIS Spinal System and 4CIS Low Back System | 2005 | 125 |
| K100706 | Venus Basic Spinal Fixation System | 2010 | 124 |
| K103085 | Venus Basic Spinal Fixation System | 2011 | 123 |
| K101278 | Inertia Pedicle Screw System | 2010 | 111 |
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-1183-03 | Other | Reports of pieces chipping off the tip of screwdriver during use. |
| 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K053573 (GS Medical Co., Ltd., 2006) has gone furthest, with 181 descendants of its own.
- 8 other devices also cite its predicate K020279.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (179 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031585 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031585: U&I, Optima, Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031585
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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