510(k) · Cleared
ClearedVenus Basic Spinal Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jul 22, 2010 as substantially equivalent to K031585 (U&I Corp., America, 2003) and 3 other predicates after a 132-day review. Its family tree reaches back 5 generations to 2000. 124 later devices descend from it.
- Decided
- Jul 22, 2010
- Review
- 132 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K000319 (2000). 10 ancestors in all. 124 later devices descend from it, 6 citing it directly.
- Root · 5 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 4 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 3 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 2 generations backK053573 GSS Pedicle Screw SystemGS Medical Co., Ltd. · 2006
- 1 generation backK082509 Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008
- This deviceK100706 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2010
- Descendant · cites it directly · 123 of its ownK103085 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- Descendant · cites it directly · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
- Descendant · 2 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
- Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K103085Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011 · cites it directly123descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly111descendants
- K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · cites it directly75descendants
- K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on70descendants
- K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −4 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −3 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −2 | K053573 | GSS Pedicle Screw System | GS Medical Co., Ltd. | 2006 | — |
| −1 | K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | 2008 | — |
| 0 (this device) | K100706 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2010 | — |
| +1 | K103085 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| +1 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | Biomet Spine (Aka Ebi, LLC) | 2013 | 2 |
| +2 | K131615 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2013 | — |
| +2 | K133746 | Polaris Spinal System | Biomet Spine (Aka Ebi, LLC) | 2014 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 4 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 2 | 0 |
| 2014 | 5 | 0 |
| 2015 | 6 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 5 | 0 |
| 2020 | 11 | 0 |
| 2021 | 6 | 0 |
| 2022 | 10 | 0 |
| 2023 | 16 | 0 |
| 2024 | 13 | 0 |
| 2025 | 11 | 0 |
| 2026 | 15 | 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? (4)
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 |
|---|---|---|---|
| * | K031585 | U&I, Optima, Spinal SystemSummary page 2…ENUS BASIC Spinal Fixation System, is substantially equivalent to OPTIMATM, Spinal System manufactured by U & I Co., Ltd which was cleared for marketing as K03 1585, the Global Spinal Fixation System manufactured by D.K.M. Co., Ltd which was cleared for marketing as K001668, the 4CIS Va… | 2003 |
| * | K001668 | Global Spinal Fixation SystemSummary page 2…Co., Ltd which was cleared for marketing as K03 1585, the Global Spinal Fixation System manufactured by D.K.M. Co., Ltd which was cleared for marketing as K001668, the 4CIS Vane Spine System manufactured by Solco Biomedical Co., Ltd which was cleared for marketing as K060702 an… | 2000 |
| * | K060702 | 4CIS Vane Spine SystemSummary page 2…o., Ltd which was cleared for marketing as K001668, the 4CIS Vane Spine System manufactured by Solco Biomedical Co., Ltd which was cleared for marketing as K060702 and the EOS Spinal System manufactured by Korea Bone Bank Co., Ltd which was cleared for marketing as K082509. Device Des… | 2006 |
| * | K082509 | Eos Spinal SystemSummary page 2…l Co., Ltd which was cleared for marketing as K060702 and the EOS Spinal System manufactured by Korea Bone Bank Co., Ltd which was cleared for marketing as K082509. Device Description The VENUS BASIC Spinal Fixation System is a top-loading multiple component, posterior spinal F… | 2008 |
What descends from it? (124)
See all 1246 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103085 | Venus Basic Spinal Fixation System | 2011 | 123 |
| K120270 | Venus Spinal Fixation System | 2012 | 111 |
| K123549 | Polaris Spinal System - Ballista II Percutaneous Screw Placement System | 2013 | 75 |
| K112643 | Focus Mis System | 2012 | 26 |
| K120140 | Focus Spinal System | 2012 | 25 |
| K121568 | Dali Spinal Fixation System | 2012 | 1 |
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 10 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K103085 (L&K BIOMED Co., Ltd., 2011) has gone furthest, with 123 descendants of its own.
- 40 other devices also cite its predicate K031585.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 VENUS BASIC Spinal Fixation System are a pedicle screw system indicated for the treatment of severe Spondylolisthesis (Grade 3 and 4) of, the L5-S1I 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 VENUS BASIC Spinal Fixation System are intended to provide…
Read the full statement (125 words)
The VENUS BASIC Spinal Fixation System are a pedicle screw system indicated for the
treatment of severe Spondylolisthesis (Grade 3 and 4) of, the L5-S1I 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 VENUS BASIC Spinal Fixation System are 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100706 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100706: Venus Basic Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100706
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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