510(k) · Cleared
Recalled · 2004Optima, Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
U&I Corp., America · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Mar 12, 2003 as substantially equivalent to K020279 (Forex Corp., 2002) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 2000. 466 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 12, 2003
- Review
- 90 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 2 generations to K000319 (2000). 4 ancestors in all. 466 later devices descend from it, 30 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 deviceK024096 Optima, Spinal SystemU&I Corp., America · 2003
- Descendant · cites it directly · 150 of its ownK091725 Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020…U&I Corp. · 2009
- Descendant · cites it directly · 138 of its ownK120291 OP Spine SystemOrthoPediatrics Corp. · 2012
- Descendant · 2 generations on · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
- Descendant · cites it directly · 123 of its ownK103085 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- Descendant · 2 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
Showing 5 of 466 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 466 · See all- K091725Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)U&I Corp. · 2009 · cites it directly150descendants
- K120291OP Spine SystemOrthoPediatrics Corp. · 2012 · cites it directly138descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · 2 generations on127descendants
- K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · cites it directly123descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 2 generations on111descendants
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) | K024096 | Optima, Spinal System | U&I Corp., America | 2003 | — |
| +1 | K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) | U&I Corp. | 2009 | — |
| +1 | K120291 | OP Spine System | OrthoPediatrics Corp. | 2012 | — |
| +2 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| +1 | K103085 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| +2 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
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 |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 3 | 0 |
| 2010 | 7 | 0 |
| 2011 | 5 | 0 |
| 2012 | 17 | 0 |
| 2013 | 21 | 0 |
| 2014 | 20 | 0 |
| 2015 | 25 | 0 |
| 2016 | 25 | 0 |
| 2017 | 19 | 0 |
| 2018 | 34 | 0 |
| 2019 | 19 | 0 |
| 2020 | 34 | 0 |
| 2021 | 26 | 0 |
| 2022 | 34 | 0 |
| 2023 | 49 | 0 |
| 2024 | 39 | 0 |
| 2025 | 38 | 0 |
| 2026 | 38 | 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? (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: OPTIMATM,Spinal System MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Strykem Spine, Xia” Spinal System - MNH,… | 2002 |
| * | K002059 | Amt Spinal SystemSummary page 1…mposition, labeling, and intended use to: OPTIMATM,Spinal System MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Strykem Spine, Xia” Spinal System - MNH, MNI, KWQ - (K001319) The substantial equivalence of this device is based… | 2000 |
| * | K001319 | Xia Spine System HooksSummary page 1…tem MNH, MNI, KWQ - (K020279). Micron Precision Engineering, AMT Spinal System - KWP, MNH -- (K002059) Strykem Spine, Xia” Spinal 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? (466)
See all 46630 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549) | 2009 | 150 |
| K120291 | OP Spine System | 2012 | 138 |
| K103085 | Venus Basic Spinal Fixation System | 2011 | 123 |
| K101278 | Inertia Pedicle Screw System | 2010 | 111 |
| K071857 | Delta Spinal Fusion System | 2007 | 109 |
| K072022 | Valeo Pedicle Screw Spinal System | 2007 | 100 |
| K102204 | Choice Spine Starfire Pedicle Screw System | 2010 | 88 |
| K043152 | Vertebron PSS Pedicle Screw System | 2005 | 61 |
| K051716 | Vertebron PSS Pedicle Screw System | 2005 | 56 |
| K121115 | M.U.S.T Pedicle Screw System | 2012 | 43 |
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. |
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, K091725 (U&I Corp., 2009) has gone furthest, with 150 descendants of its own.
- 8 other devices also cite its predicate K020279.
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 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…
Read the full statement (179 words)
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,
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024096 · printed Nov 3, 2026
Cite this page
510(k) Report. “K024096: Optima, Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K024096
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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