510(k) · Cleared
ClearedLexus Cervical Intervertebral Body Fusion Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
L&K BIOMED Co., Ltd. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on May 24, 2012 as substantially equivalent to K091088 (Ldr Spine USA, 2009) and 4 other predicates after a 65-day review. Its family tree reaches back 11 generations to 1984. 14 later devices descend from it.
- Decided
- May 24, 2012
- Review
- 65 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 45 ancestors in all. 14 later devices descend from it, 3 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- This deviceK120840 Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 9 of its ownK143360 LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 2 generations on · 8 of its ownK151677 LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 3 generations on · 5 of its ownK202872 Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021
- Descendant · 4 generations on · 4 of its ownK213980 Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022
- Descendant · 5 generations on · 3 of its ownK230708 Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion…Gbs Commonwealth Co., Ltd. · 2023
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 5 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 4 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 3 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 2 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 1 generation backK113559 LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsLdr Spine USA, Inc. · 2011
- This deviceK120840 Lexus Cervical Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K143360LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015 · cites it directly9descendants
- K151677LnK Cervical Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015 · 2 generations on8descendants
- K202872Prase PEEK Anterior Cervical Interbody SpacerGbs Commonwealth Co., Ltd. · 2021 · 3 generations on5descendants
- K213980Peridot Spinal Interbody SystemGbs Commonwealth Co., Ltd. · 2022 · 4 generations on4descendants
- K230708Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…Gbs Commonwealth Co., Ltd. · 2023 · 5 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −5 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −4 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −3 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −2 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −1 | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic Implants | Ldr Spine USA, Inc. | 2011 | — |
| 0 (this device) | K120840 | Lexus Cervical Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K143360 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| +2 | K151677 | LnK Cervical Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| +3 | K202872 | Prase PEEK Anterior Cervical Interbody Spacer | Gbs Commonwealth Co., Ltd. | 2021 | — |
| +4 | K213980 | Peridot Spinal Interbody System | Gbs Commonwealth Co., Ltd. | 2022 | — |
| +5 | K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system)… | Gbs Commonwealth Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 5 | 0 |
| 2003 | 2 | 0 |
| 2004 | 7 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2025 | 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 ODP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K091088 | LDR Spine Cervical Interbody Fusion SystemSummary page 1…vical Intervertebral body Fusion Cage System is substantially equivalent to the following predicates: *LDR Spine: LDR Spine Cervical Interbody Fusion System (K091088,K1 13559) * Spine Art: TRYPTIK CA Anterior Intersomatic Cervical Cage (K091 873) *Advanced Medical Technologies AG: S… | 2009 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 1…Intervertebral body Fusion Cage System is substantially equivalent to the following predicates: *LDR Spine: LDR Spine Cervical Interbody Fusion System (K091088,K1 13559) * Spine Art: TRYPTIK CA Anterior Intersomatic Cervical Cage (K091 873) *Advanced Medical Technologies AG: SHELL Cage… | 2011 |
| * | K091873 | Tryptik CA Anterior Intersomatic Cervical Cage, Models Mos-CA 12 05-S, Mos-CA 12 O6-SSummary page 1…llowing predicates: *LDR Spine: LDR Spine Cervical Interbody Fusion System (K091088,K1 13559) * Spine Art: TRYPTIK CA Anterior Intersomatic Cervical Cage (K091 873) *Advanced Medical Technologies AG: SHELL Cages (K080401) * Globus Medical Inc.: COALITION TMSpacer (K083389) 4. Des… | 2009 |
| * | K080401 | Shell Cage, Wave Cage, Loop CageSummary page 1…rbody Fusion System (K091088,K1 13559) * Spine Art: TRYPTIK CA Anterior Intersomatic Cervical Cage (K091 873) *Advanced Medical Technologies AG: SHELL Cages (K080401) * Globus Medical Inc.: COALITION TMSpacer (K083389) 4. Description of the Device LEXUS Cervical Intervertebral body Fu… | 2008 |
| * | K083389 | Coalition SpacerSummary page 1…TRYPTIK CA Anterior Intersomatic Cervical Cage (K091 873) *Advanced Medical Technologies AG: SHELL Cages (K080401) * Globus Medical Inc.: COALITION TMSpacer (K083389) 4. Description of the Device LEXUS Cervical Intervertebral body Fusion Cage System intended for use as an interbody fusio… | 2009 |
What descends from it? (14)
See all 143 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 28 years and passes through 8 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 45 ancestors have a recall of any class.
- Of its descendants, K143360 (L&K BIOMED Co., Ltd., 2015) has gone furthest, with 9 descendants of its own.
- 50 other devices also cite its predicate K091088.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
LEXUS Cervical Intervertebral body Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LEXUS Cervical Intervertebral body Fusion Cage System is used to facilitate intervertebral body fusion in the cervical…
Read the full statement (110 words)
LEXUS Cervical Intervertebral body Fusion Cage System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. LEXUS Cervical Intervertebral body Fusion Cage System is used to facilitate intervertebral body fusion in the cervical spine at the C3 to C7 disc levels using autograft bone. LEXUS Cervical Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120840 · printed Nov 4, 2026
Cite this page
510(k) Report. “K120840: Lexus Cervical Intervertebral Body Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120840
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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