510(k) · Cleared
ClearedVenus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage
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 Oct 24, 2011 as substantially equivalent to K100516 (GS Medical Co., Ltd., 2010) and 9 other predicates after a 217-day review. Its family tree reaches back 9 generations to 2001. 38 later devices descend from it.
- Decided
- Oct 24, 2011
- Review
- 217 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 9 generations to K003155 (2001). 39 ancestors in all, the oldest K841189 (1984). 38 later devices descend from it, 7 citing it directly.
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 5 generations between
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK053508 Synfix-LRSynthes Spine Co.Lp · 2006 · Recalled
- This deviceK110783 Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd. · 2011
- Descendant · cites it directly · 37 of its ownK120063 Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012
- Descendant · cites it directly · 36 of its ownK121096 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
Show all 9 generations
- Root · 9 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations backK012254 VBROsteotech, Inc. · 2001
- 7 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 6 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 5 generations backK031780 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 4 generations backK040731 Stryker Spine Vertebral SpacerStryker Spine · 2004
- 3 generations backK042571 Stryker Spine Avs TL Peek SpacerStryker Spine · 2005
- 2 generations backK050624 Stryker Spine Avs PL Peek SpacerStryker Spine · 2005
- 1 generation backK053508 Synfix-LRSynthes Spine Co.Lp · 2006 · Recalled
- This deviceK110783 Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek CageL&K BIOMED Co., Ltd. · 2011
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K120063Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly37descendants
- K121096Venus Lumbar Intervertebral Body Fusion Cage SystemL&K BIOMED Co., Ltd. · 2012 · cites it directly36descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −8 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −7 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −6 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −5 | K031780 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −4 | K040731 | Stryker Spine Vertebral Spacer | Stryker Spine | 2004 | — |
| −3 | K042571 | Stryker Spine Avs TL Peek Spacer | Stryker Spine | 2005 | — |
| −2 | K050624 | Stryker Spine Avs PL Peek Spacer | Stryker Spine | 2005 | — |
| −1 | K053508 | Synfix-LR | Synthes Spine Co.Lp | 2006 | 1 |
| 0 (this device) | K110783 | Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage | L&K BIOMED Co., Ltd. | 2011 | — |
| +1 | K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | L&K BIOMED Co., Ltd. | 2012 | — |
| +1 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 3 | 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? (10)
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 |
|---|---|---|---|
| * | K100516 | Anyplus Peek CagesSummary page 1…888.3080) Product Code MAX 3. Predicate or legally marketed devices which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art… | 2010 |
| * | K083661 | Avs TL Peek SpacersSummary page 1…MAX 3. Predicate or legally marketed devices which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * So… | 2009 |
| * | K090816 | Stryker Spine Avs PL Peek SpacersSummary page 1…MAX 3. Predicate or legally marketed devices which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biom… | 2009 |
| * | K093704 | Avs PL Peek SpacersSummary page 1…MAX 3. Predicate or legally marketed devices which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical:… | 2009 |
| * | K053508 | Synfix-LRSummary page 1…lly marketed devices which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical: K092162 4. Description o… | 2006 |
| * | K062083 | Synfix -LRSummary page 1…ted devices which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical: K092162 4. Description of the Dev… | 2007 |
| * | K072253 | Synfix-LR SpacerSummary page 1…es which are substantially equivalent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical: K092162 4. Description of the Device… | 2007 |
| * | K081888 | Dynamik Intervertebral Body Fusion DeviceSummary page 1…ent GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical: K092162 4. Description of the Device The VENUS Lumbar lntervertebra… | 2009 |
| * | K101720 | Juliet OLSummary page 1…GS Medical: K100516 * Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical: K092162 4. Description of the Device The VENUS Lumbar lntervertebral body Fusi… | 2010 |
| * | K092162 | 4CIS Peek, Plif and Tlif Cage SystemSummary page 1…* Stryker Spine: K083661,K090816,K093704 * Synthes : K053508, K062083, K072253 *Spine Art : K081888, K 10 1720 * Solco Biomedical: K092162 4. Description of the Device The VENUS Lumbar lntervertebral body Fusion Cage devices intended for use as an ai… | 2010 |
What descends from it? (38)
See all 387 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120063 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 37 |
| K121096 | Venus Lumbar Intervertebral Body Fusion Cage System | 2012 | 36 |
| K151140 | LnK Lumbar Interbody Fusion Cage System | 2015 | 29 |
| K190708 | AccelFix Lumbar Interbody Fusion Cage System | 2019 | 5 |
| K121567 | Oracle Lumbar Intervertebral Body Fusion Cage System | 2012 | 5 |
| K213441 | PathLoc Lumbar Interbody Fusion Cage System | 2022 | 2 |
| K181963 | ostaPek Interbody Fusion Cages | 2018 | 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 10 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 4 of the 39 ancestors have a recall of any class.
- Of its descendants, K120063 (L&K BIOMED Co., Ltd., 2012) has gone furthest, with 37 descendants of its own.
- 11 other devices also cite its predicate K100516.
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. 2011, 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-SI. DOD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODD patients may also have up to Grade I spdndylolistesis 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-SI. DOD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODD patients may also have up to Grade I spdndylolistesis 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/K110783 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110783: Venus Interbody Fixation System- Venus Plif/Tlif, Alif Peek Cage.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110783
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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