510(k) · Cleared
Recalled · Class II · 2016Biomet Spine Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Jan 21, 2016 as substantially equivalent to K151483 (Biomet Spine, LLC, 2015) after a 29-day review. Its family tree reaches back 13 generations to 1984. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 21, 2016
- Review
- 29 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 13 generations to K841189 (1984). 45 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 9 generations between
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK142634 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
- 1 generation backK151483 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
- This deviceK153695 Biomet Spine Fusion SystemBiomet Spine, LLC · 2016
- Descendant · cites it directly · 1 of its ownK171495 Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK251479 Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar…Mobarn Medical Devices, LLC · 2025
- Descendant · cites it directly · 0 of its ownK181096 Avenue P Cage SystemZimmer Biomet Spine, Inc. · 2019
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 backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 9 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 8 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 7 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 6 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 5 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 4 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 3 generations backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- 2 generations backK142634 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
- 1 generation backK151483 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
- This deviceK153695 Biomet Spine Fusion SystemBiomet Spine, LLC · 2016
Most influential descendants
Showing 3 of 3 · See all- K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018 · cites it directly1descendant
- K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC · 2025 · 2 generations on0descendants
- K181096Avenue P Cage SystemZimmer Biomet Spine, Inc. · 2019 · cites it directly0descendants
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 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −9 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −8 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −7 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −6 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −5 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −4 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −3 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| −2 | K142634 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015 | — |
| −1 | K151483 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015 | — |
| 0 (this device) | K153695 | Biomet Spine Fusion System | Biomet Spine, LLC | 2016 | — |
| +1 | K171495 | Zyston Strut Open Titanium Spacer System | Zimmer Biomet Spine, Inc. | 2018 | — |
| +2 | K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion… | Mobarn Medical Devices, LLC | 2025 | — |
| +1 | K181096 | Avenue P Cage System | Zimmer Biomet Spine, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 5 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2025 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K151483 | Biomet Spine Fusion SystemSummary page 4…MAX Device Panel – Regulation No.: Orthopedic – 21 CFR 888.3080 Primary Predicate: Biomet Spine Fusion System K151483 Device Description: The Biomet Spine Fusion System implants are intervertebral body fusion/vertebral body replacement devices co… | 2015 |
What descends from it? (3)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 30, 2016 | Class II | Z-2398-2016 | Under Investigation by firm | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. |
| Jun 30, 2016 | Class II | Z-2397-2016 | Under Investigation by firm | Zimmer Bioment Spine, Inc. announces a voluntary field action for the Zyston¿ Transform Instrument Case and Zyston¿ Transform Implant Kit because the locking mechanism on the implant is not functioning as intended. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 45 ancestors have a recall of any class.
- Of its descendants, K171495 (Zimmer Biomet Spine, Inc., 2018) has gone furthest, with 1 descendant of its own.
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. 2016, 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?
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of…
Read the full statement (149 words)
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System is intended for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients with degenerative disc disease (“DDD”) at one or two contiguous spinal levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six months of non-operative treatment. These DDD patients may have had a previous non-fusion spinal surgery at the involved spinal level(s), and may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Biomet Spine Fusion System is to be implanted via an anterior or posterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Spine Spinal Fixation System. The expandable interbody fusion devices are not indicated for vertebral body replacement
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153695: Biomet Spine Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153695
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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