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 Feb 9, 2011 as substantially equivalent to K100706 (L&K BIOMED Co., Ltd., 2010) and 12 other predicates after a 113-day review. Its family tree reaches back 6 generations to 2000. 123 later devices descend from it.
- Decided
- Feb 9, 2011
- Review
- 113 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 6 generations to K000319 (2000). 20 ancestors in all, the oldest K980485 (1998). 123 later devices descend from it, 6 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 backK082509 Eos Spinal SystemKorea Bone Bank Co., Ltd. · 2008
- 1 generation backK100706 Venus Basic Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2010
- This deviceK103085 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
- Descendant · 2 generations on · 33 of its ownK143363 VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015
Showing 5 of 123 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 123 · See all- 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
- K143363VENUS Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on33descendants
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 | K082509 | Eos Spinal System | Korea Bone Bank Co., Ltd. | 2008 | — |
| −1 | K100706 | Venus Basic Spinal Fixation System | L&K BIOMED Co., Ltd. | 2010 | — |
| 0 (this device) | 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 |
| +2 | K143363 | VENUS Spinal Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 4 | 0 |
| 2003 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (13)
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 |
|---|---|---|---|
| * | K100706 | Venus Basic Spinal Fixation SystemSummary page 1…t in function, design, composition, labeling and intended use to: *L&K BIOMED Co., Ltd. VENUS BASIC Spinal Fixation System(K1 00706) *D.K.M. Co., Ltd. Global Spinal Fixation System (KOO01668) *U & I Co., Ltd. O… | 2010 |
| * | K001668 | Global Spinal Fixation System | 2000 |
| * | K091725 | Perfix Spinal System, Model SNA4530-9610, SNM4530-9610, SN3020 (Total: 549)Summary page 1…*D.K.M. Co., Ltd. Global Spinal Fixation System (KOO01668) *U & I Co., Ltd. OPTIMA h Spinal System (K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System… | 2009 |
| * | K051971 | Optima Spinal SystemSummary page 1…*D.K.M. Co., Ltd. Global Spinal Fixation System (KOO01668) *U & I Co., Ltd. OPTIMA h Spinal System (K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081… | 2005 |
| * | K042928 | Modification to Global Spinal Fixation SystemSummary page 1….K.M. Co., Ltd. Global Spinal Fixation System (KOO01668) *U & I Co., Ltd. OPTIMA h Spinal System (K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K0824… | 2005 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…, Ltd. Global Spinal Fixation System (KOO01668) *U & I Co., Ltd. OPTIMA h Spinal System (K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K0607… | 2003 |
| * | K024096 | Optima, Spinal SystemSummary page 1…Global Spinal Fixation System (KOO01668) *U & I Co., Ltd. OPTIMA h Spinal System (K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K05047… | 2003 |
| * | K081145 | Modification to 4CIS Vane Spine SystemSummary page 1…tem (K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K050471 1<043578) *Korea Bone Bank Co., Ltd. EQS Spinal System (K082509) L… | 2008 |
| * | K082453 | 4CIS Solar and Apollon Spine SystemsSummary page 1…(K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K050471 1<043578) *Korea Bone Bank Co., Ltd. EQS Spinal System (K082509) L&K BIOME… | 2008 |
| * | K060702 | 4CIS Vane Spine SystemSummary page 1…(K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K050471 1<043578) *Korea Bone Bank Co., Ltd. EQS Spinal System (K082509) L&K BIOMED Co.,Ltd… | 2006 |
| * | K050471 | 4CIS Solar Spine System and 4CIS Apollon Spine SystemSummary page 1…(K091725, K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K050471 1<043578) *Korea Bone Bank Co., Ltd. EQS Spinal System (K082509) L&K BIOMED Co.,Ltd. Specia… | 2005 |
| * | K043578 | The 4CIS Spinal System and 4CIS Low Back SystemSummary page 1…K051 971, K042928, K031585, K024096) *Solco Biomedical Co., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K050471 1<043578) *Korea Bone Bank Co., Ltd. EQS Spinal System (K082509) L&K BIOMED Co.,Ltd. Special 5 10K… | 2005 |
| * | K082509 | Eos Spinal SystemSummary page 1…., Ltd. 4C15 Vane Spine System (K081 145,K082453, K060702,K050471 1<043578) *Korea Bone Bank Co., Ltd. EQS Spinal System (K082509) L&K BIOMED Co.,Ltd. Special 5 10K Page 15 /48 === Page 2… | 2008 |
What descends from it? (123)
See all 1236 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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 |
| K162801 | CastleLoc Spinal Fixation System | 2016 | 4 |
| K120714 | Picasso Mis Spinal Fixation System | 2012 | 2 |
| 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 11 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 3 of the 20 ancestors have a recall of any class.
- Of its descendants, K120270 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 111 descendants of its own.
- 5 other devices also cite its predicate K100706.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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 VENUS BASIC Spinal Fixation System is intended to provide…
Read the full statement (125 words)
The VENUS BASIC Spinal Fixation System 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 VENUS BASIC Spinal Fixation System 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).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103085 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103085: Venus Basic Spinal Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103085
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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