510(k) · Cleared
ClearedVenus Lumbar 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. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jul 6, 2012 as substantially equivalent to K110783 (L&K BIOMED Co., Ltd., 2011) and 15 other predicates after an 86-day review. Its family tree reaches back 13 generations to 1984. 36 later devices descend from it.
- Decided
- Jul 6, 2012
- Review
- 86 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 13 generations to K841189 (1984). 74 ancestors in all. 36 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 29 of its ownK151140 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015
- Descendant · 2 generations on · 10 of its ownK181380 LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018
- Descendant · 2 generations on · 8 of its ownK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK192026 Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019
- Descendant · 3 generations on · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
Show all 13 generations
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 12 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 11 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 10 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 7 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 6 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 3 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 2 generations backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 1 generation backK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- This deviceK121096 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K151140LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2015 · cites it directly29descendants
- K181380LnK Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2018 · 2 generations on10descendants
- K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on8descendants
- K192026Peridot Intervertebral body fusion SystemGbs Commonwealth Co., Ltd. · 2019 · 2 generations on6descendants
- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −12 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −11 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −10 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −7 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −6 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −3 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −2 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −1 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| 0 (this device) | K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | K151140 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2015 | — |
| +2 | K181380 | LnK Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2018 | — |
| +2 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +2 | K192026 | Peridot Intervertebral body fusion System | Gbs Commonwealth Co., Ltd. | 2019 | — |
| +3 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 8 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (16)
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 |
|---|---|---|---|
| * | K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | 2011 |
| * | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System Cleared while this submission was under review Summary page 2…ody Fusion Cage System does not constitute a new worst case for the intended use and is substantially equivalent to the predicate device (KI 10783, K 120063). 7. Summary of technology characteristics The VENUS Lumbar Intervertebral body Fusion Cage System shares… | 2012 |
| * | K100516 | Anyplus Peek CagesSummary page 2…L&K BIOMED: VENUS Lumbar Intervertebral Body Fusion Cage System (KI 10783, K120063) ..CS Medical: Any Plus PEEK Cage (K 100516) STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage S… | 2010 |
| * | K083661 | Avs TL Peek SpacersSummary page 2…Cage System (KI 10783, K120063) ..CS Medical: Any Plus PEEK Cage (K 100516) STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent Syste… | 2009 |
| * | K090816 | Stryker Spine Avs PL Peek SpacersSummary page 2…stem (KI 10783, K120063) ..CS Medical: Any Plus PEEK Cage (K 100516) STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K0434… | 2009 |
| * | K093704 | Avs PL Peek SpacersSummary page 2…(KI 10783, K120063) ..CS Medical: Any Plus PEEK Cage (K 100516) STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K043405,K0522… | 2009 |
| * | K092162 | 4CIS Peek, Plif and Tlif Cage SystemSummary page 2…cal: Any Plus PEEK Cage (K 100516) STRYKER SPINE :AVS PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Int… | 2010 |
| * | K043405 | Nuvasive Coroent SystemSummary page 2…PINE :AVS PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K… | 2005 |
| * | K052210 | Nuvasive Coroent Extensure SystemSummary page 2…S PEEK Spacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888,… | 2005 |
| * | K071795 | Nuvasive Coroent SystemSummary page 2…pacer System (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720)… | 2007 |
| * | K081611 | Nuvasive Coroent SystemSummary page 2…tem (K083661,K090816,K093704) *Solco Biomedical : 4CIS PEEK PLIF Cage System (K092162) Nuvasive: NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720)… | 2008 |
| * | K081888 | Dynamik Intervertebral Body Fusion DeviceSummary page 2…uvasive: NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720) Medtronic Sofamor Danek: CLYDESDALE Spinal System (K1001 75,KI… | 2009 |
| * | K101720 | Juliet OLSummary page 2…NuVasive CoRoent System (K043405,K052210 K071795, K08161 1) Spine Art : JULIET OL, DYNAMIK Intervertebral body fusion device (K081888, K101720) Medtronic Sofamor Danek: CLYDESDALE Spinal System (K1001 75,KI 12405,KI… | 2010 |
| * | K100175 | Clydesdale Spinal SystemSummary page 2…body fusion device (K081888, K101720) Medtronic Sofamor Danek: CLYDESDALE Spinal System (K1001 75,KI 12405,KI 113528) 9. Conclusion The VENUS Lumbar Intervertebral body Fusion Cage System is substantially equiv… | 2010 |
| * | K112405 | Clydesdales Spinal System | 2011 |
| * | K113528 | Clydesdale (R) Spinal SystemSummary page 2…(K081888, K101720) Medtronic Sofamor Danek: CLYDESDALE Spinal System (K1001 75,KI 12405,KI 113528) 9. Conclusion The VENUS Lumbar Intervertebral body Fusion Cage System is substantially equivalent to the… | 2011 |
What descends from it? (36)
See all 364 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 10 companies; a new generation was cleared every 1.0 years on median.
- 7 of the 74 ancestors have a recall of any class.
- Of its descendants, K151140 (L&K BIOMED Co., Ltd., 2015) has gone furthest, with 29 descendants of its own.
- 6 other devices also cite its predicate K110783.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).This…
Read the full statement (108 words)
VENUS Lumbar Intervertebral body Fusion Cage System is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s).This device is to be used with autogenous bone graft. VENUS Lumbar Intervertebral body Fusion Cage System is to be used with supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121096 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121096: Venus Lumbar Intervertebral Body Fusion Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121096
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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