510(k) · Cleared
ClearedLexus Cervical 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 May 23, 2012 as substantially equivalent to K031985 (Spinal Concepts, Inc., 2003) and 4 other predicates after a 61-day review. Its family tree reaches back 11 generations to 1985. 15 later devices descend from it.
- Decided
- May 23, 2012
- Review
- 61 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K853033 (1985). 22 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 7 generations between
- 3 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 2 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 1 generation backK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- This deviceK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 13 of its ownK143278 LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 2 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
- Descendant · 2 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
Show all 11 generations
- Root · 11 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 10 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- 9 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- 8 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- 7 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- 6 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- 5 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- 4 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
- 3 generations backK050979 S4 Spinal SystemAesculap, Inc. · 2005
- 2 generations backK060152 Modification to S4 Spinal SystemAesculap, Inc. · 2006
- 1 generation backK103414 Venus Cervical Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2011
- This deviceK120879 Lexus Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2012
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015 · cites it directly13descendants
- K162136CastleLoc-S Posterior Cervical Fixation System; LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2016 · 2 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
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −10 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| −9 | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| −8 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| −7 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| −6 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| −5 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| −4 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
| −3 | K050979 | S4 Spinal System | Aesculap, Inc. | 2005 | — |
| −2 | K060152 | Modification to S4 Spinal System | Aesculap, Inc. | 2006 | — |
| −1 | K103414 | Venus Cervical Spinal Fixation System | L&K BIOMED Co., Ltd. | 2011 | — |
| 0 (this device) | K120879 | Lexus Cervical Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | 2015 | — |
| +2 | 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 | — |
| +2 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
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 | 1 | 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? (5)
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…l Fixation Orthosis (2ICFRSS8.3050) 3. Predicate or legally marketed devices which are substantially equivalent * Spinal Concept Inc. / Nex-Link Spinal Fixation (K03 1985) * Aesculap Inc. / S4 Spinal Fixation (K050979, K060 152) * Medtronic Sofamor Danek USA Inc. / VERTEX TMReconstruction… | 2003 |
| * | K050979 | S4 Spinal SystemSummary page 1…r legally marketed devices which are substantially equivalent * Spinal Concept Inc. / Nex-Link Spinal Fixation (K03 1985) * Aesculap Inc. / S4 Spinal Fixation (K050979, K060 152) * Medtronic Sofamor Danek USA Inc. / VERTEX TMReconstruction System (K003780) * L&K BIOMED Co.,Ltd. / LEXUS… | 2005 |
| * | K060152 | Modification to S4 Spinal SystemSummary page 1…marketed devices which are substantially equivalent * Spinal Concept Inc. / Nex-Link Spinal Fixation (K03 1985) * Aesculap Inc. / S4 Spinal Fixation (K050979, K060 152) * Medtronic Sofamor Danek USA Inc. / VERTEX TMReconstruction System (K003780) * L&K BIOMED Co.,Ltd. / LEXUS Cervical F… | 2006 |
| * | K003780 | Vertex Reconstruction SystemSummary page 1…x-Link Spinal Fixation (K03 1985) * Aesculap Inc. / S4 Spinal Fixation (K050979, K060 152) * Medtronic Sofamor Danek USA Inc. / VERTEX TMReconstruction System (K003780) * L&K BIOMED Co.,Ltd. / LEXUS Cervical Fixation System (K 103414) 4. Description of the Device The purpose of thi… | 2001 |
| * | K103414 | Venus Cervical Spinal Fixation SystemSummary page 1…ation (K050979, K060 152) * Medtronic Sofamor Danek USA Inc. / VERTEX TMReconstruction System (K003780) * L&K BIOMED Co.,Ltd. / LEXUS Cervical Fixation System (K 103414) 4. Description of the Device The purpose of this 5 10(k) submission is to add reduction polyaxial screws and curved… | 2011 |
What descends from it? (15)
See all 154 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 27 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K143278 (L&K BIOMED Co., Ltd., 2015) has gone furthest, with 13 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. 2012, 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: * DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) * Spondylolisthesis * Spinal stenrosis * 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 allograft following the reduction of…
Read the full statement (130 words)
The LEXUS Cervical Fixation System is indicated for the following:
* DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)
* Spondylolisthesis
* Spinal stenrosis
* 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 allograft 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 pedicle 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/K120879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120879: Lexus Cervical Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120879
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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