510(k) · Cleared
ClearedVenus Cervical 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. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 22, 2011 as substantially equivalent to K031985 (Spinal Concepts, Inc., 2003) and 3 other predicates after a 242-day review. Its family tree reaches back 10 generations to 1985. 16 later devices descend from it.
- Decided
- Jul 22, 2011
- Review
- 242 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K853033 (1985). 21 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 6 generations between
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 1 generation backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- This deviceK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- Descendant · cites it directly · 15 of its ownK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · 2 generations on · 13 of its ownK143278 LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 3 generations on · 12 of its ownK162136 CastleLoc-S Posterior Cervical Fixation System; LnK Posterior…L&K BIOMED Co., Ltd. · 2016
- Descendant · cites it directly · 11 of its ownK200793 LnK Posterior Cervical Fixation System and CastleLoc-S Posterior…L&K BIOMED Co., Ltd. · 2020
- Descendant · 2 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
Show all 10 generations
- Root · 10 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 9 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 8 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 7 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 6 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 5 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 4 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 3 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 2 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 1 generation backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- This deviceK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K120879Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly15descendants
- K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on13descendants
- K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2016 · 3 generations on12descendants
- K200793LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly11descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −9 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −8 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −7 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −6 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −5 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −4 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −3 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −2 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −1 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| 0 (this device) | K103414 | Venus Cervical Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| +1 | K120879 | Lexus Cervical Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +2 | K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
| +3 | K162136 | CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical… | L&K BIOMED Co., Ltd. | 2016 | — |
| +1 | K200793 | LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical… | L&K BIOMED Co., Ltd. | 2020 | — |
| +2 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemSummary page 1…lass Class 11 3. Predicate or legally marketed devices which are substantially equivalent - Spinal Concept,lnc. / Nex-Link Spinal Fixation (K03 1985) - Aesculap, Inc. / S4 Spinal Fixation (K050979, K060152) - Medtronic Sofamor Danek USA,lnc. / VE… | 2003 |
| * | K050979 | S4 Spinal SystemSummary page 1…d devices which are substantially equivalent - Spinal Concept,lnc. / Nex-Link Spinal Fixation (K03 1985) - Aesculap, Inc. / S4 Spinal Fixation (K050979, K060152) - Medtronic Sofamor Danek USA,lnc. / VERTEX TmReconstruction System (K003780)… | 2005 |
| * | K060152 | Modification to S4 Spinal SystemSummary page 1…which are substantially equivalent - Spinal Concept,lnc. / Nex-Link Spinal Fixation (K03 1985) - Aesculap, Inc. / S4 Spinal Fixation (K050979, K060152) - Medtronic Sofamor Danek USA,lnc. / VERTEX TmReconstruction System (K003780)… | 2006 |
| * | K003780 | Vertex Reconstruction SystemSummary page 1…(K03 1985) - Aesculap, Inc. / S4 Spinal Fixation (K050979, K060152) - Medtronic Sofamor Danek USA,lnc. / VERTEX TmReconstruction System (K003780) Page 12 /49… | 2001 |
What descends from it? (16)
See all 164 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 26 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K120879 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 15 descendants of its own.
- 9 other devices also cite its predicate K031985.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 LEXUS Cervical Fixation System is indicated for the following: * DD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal stenosis * Fracture/dislocation * Failed previous fusion * Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allografi following the reduction of…
Read the full statement (130 words)
The LEXUS Cervical Fixation System is indicated for the following:
* DD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
* Spondylolisthesis
* Spinal stenosis
* Fracture/dislocation
* Failed previous fusion
* Tumors
The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allografi following the reduction of fractures/dislocations or trauma in the spine.
Hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (ClI -T3) spine.
The pedicle screws are limited to placement in TI -T3 in treating thoracic conditions only. The pedlicle screws are not intended to be placed in or treat conditions involving the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103414 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103414: Venus Cervical 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/K103414
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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