510(k) · Cleared
ClearedLumFix Spinal Fixation Sytem
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CG Bio Co., Ltd. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Oct 4, 2016 as substantially equivalent to K093104 (Medyssey Co, Ltd., 2010) and 1 other predicate after a 201-day review. Its family tree reaches back 6 generations to 2000. 6 later devices descend from it.
- Decided
- Oct 4, 2016
- Review
- 201 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K000319 (2000). 20 ancestors in all, the oldest K933881 (1994). 6 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 5 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 4 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 3 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 2 generations backK100765 Fixpine II SystemDio Medical Co., Ltd. · 2010
- 1 generation backK132101 Anax 5.5 Spinal SystemU&I Corporation · 2013
- This deviceK160731 LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
- Descendant · cites it directly · 2 of its ownK222229 Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK210420 Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK260362 QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal…MANTIZ Co., Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK250582 COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK231443 Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K222229Advanced LumFix Spinal Fixation SystemCG Bio Co., Ltd. · 2023 · cites it directly2descendants
- K210420Goblin and Goblin LS Pedicle Screw SystemsMedynus, Inc. · 2021 · cites it directly1descendant
- K260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS…MANTIZ Co., Ltd. · 2026 · 2 generations on0descendants
- K250582COLONNADE Posterior Screw Fixation SystemCG Bio Co., Ltd. · 2025 · cites it directly0descendants
- K231443Mini-OSTEO Pedicle Fixation SystemOsteomed Indústria E Comércio DE Implantes Ltda · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −5 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −4 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −3 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −2 | K100765 | Fixpine II System | Dio Medical Co., Ltd. | 2010 | — |
| −1 | K132101 | Anax 5.5 Spinal System | U&I Corporation | 2013 | — |
| 0 (this device) | K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016 | — |
| +1 | K222229 | Advanced LumFix Spinal Fixation System | CG Bio Co., Ltd. | 2023 | — |
| +1 | K210420 | Goblin and Goblin LS Pedicle Screw Systems | Medynus, Inc. | 2021 | — |
| +2 | K260362 | QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS… | MANTIZ Co., Ltd. | 2026 | — |
| +1 | K250582 | COLONNADE Posterior Screw Fixation System | CG Bio Co., Ltd. | 2025 | — |
| +2 | K231443 | Mini-OSTEO Pedicle Fixation System | Osteomed Indústria E Comércio DE Implantes Ltda | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K093104 | Medyssey CO., LTD., Zenius Spinal SystemSummary page 5…ailed previous fusion (pseudarthrosis). Predicate Devices The subject device is substantially equivalent to the following predicate devices: Primary Predicate - K093104 Zenius™ Spinal System, Medyssey Co., Ltd. Additional Predicate - K132101 ANAX™ 5.5 Spinal System, U&I Corporation Summary… | 2010 |
| * | K132101 | Anax 5.5 Spinal SystemSummary page 5…ice is substantially equivalent to the following predicate devices: Primary Predicate - K093104 Zenius™ Spinal System, Medyssey Co., Ltd. Additional Predicate - K132101 ANAX™ 5.5 Spinal System, U&I Corporation Summary of the Technological Characteristics The LumFix Spinal Fixation System is su… | 2013 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 7 companies; a new generation was cleared every 2.9 years on median.
- 4 of the 20 ancestors have a recall of any class.
- Of its descendants, K222229 (CG Bio Co., Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K093104.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 LumFix Spinal Fixation System, a posterior spinal fixation device, indicated for skeletally mature patients receiving fusion by autogenous bone graft with removal of the implants after the attainment of a solid fusion and is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K160731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K160731: LumFix Spinal Fixation Sytem.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160731
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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