510(k) · Cleared
ClearedBiomet 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 Mar 12, 2015 as substantially equivalent to K081968 (Spinal Elements, Inc., 2008) and 4 other predicates after a 176-day review. Its family tree reaches back 11 generations to 1984. 5 later devices descend from it.
- Decided
- Mar 12, 2015
- Review
- 176 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 11 generations to K841189 (1984). 43 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK142634 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
- Descendant · cites it directly · 4 of its ownK151483 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
- Descendant · 2 generations on · 3 of its ownK153695 Biomet Spine Fusion SystemBiomet Spine, LLC · 2016 · Recalled
- Descendant · 3 generations on · 1 of its ownK171495 Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018
- Descendant · 4 generations on · 0 of its ownK251479 Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar…Mobarn Medical Devices, LLC · 2025
- Descendant · 3 generations on · 0 of its ownK181096 Avenue P Cage SystemZimmer Biomet Spine, Inc. · 2019
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 backK020522 Modification to Surgical Titanium Mesh SystemDepuyacromed · 2002
- 7 generations backK030833 Depuy Acromed VBR SystemDepuyacromed · 2003
- 6 generations backK031635 Depuy Acromed VBR SystemDepuyacromed · 2003
- 5 generations backK041722 Modification to VBR Spinal SystemDepuy Spine, Inc. · 2004
- 4 generations backK052746 Concorde VBR Spinal SystemDepuy Spine, Inc. · 2005
- 3 generations backK090899 Depuy Spine Lateral SystemDepuy Spine, Inc. · 2009
- 2 generations backK093242 Patriot Transcontinental Llif SpacerGlobus Medical, Inc. · 2009
- 1 generation backK102293 Caliber SpacerGlobus Medical, Inc. · 2011
- This deviceK142634 Biomet Spine Fusion SystemBiomet Spine, LLC · 2015
Most influential descendants
Showing 5 of 5 · See all- K151483Biomet Spine Fusion SystemBiomet Spine, LLC · 2015 · cites it directly4descendants
- K153695Biomet Spine Fusion SystemBiomet Spine, LLC · 2016 · 2 generations on3descendants
- K171495Zyston Strut Open Titanium Spacer SystemZimmer Biomet Spine, Inc. · 2018 · 3 generations on1descendant
- K251479Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage…Mobarn Medical Devices, LLC · 2025 · 4 generations on0descendants
- K181096Avenue P Cage SystemZimmer Biomet Spine, Inc. · 2019 · 3 generations on0descendants
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 | K020522 | Modification to Surgical Titanium Mesh System | Depuyacromed | 2002 | — |
| −7 | K030833 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −6 | K031635 | Depuy Acromed VBR System | Depuyacromed | 2003 | — |
| −5 | K041722 | Modification to VBR Spinal System | Depuy Spine, Inc. | 2004 | — |
| −4 | K052746 | Concorde VBR Spinal System | Depuy Spine, Inc. | 2005 | — |
| −3 | K090899 | Depuy Spine Lateral System | Depuy Spine, Inc. | 2009 | — |
| −2 | K093242 | Patriot Transcontinental Llif Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K102293 | Caliber Spacer | Globus Medical, Inc. | 2011 | — |
| 0 (this device) | K142634 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015 | — |
| +1 | K151483 | Biomet Spine Fusion System | Biomet Spine, LLC | 2015 | — |
| +2 | K153695 | Biomet Spine Fusion System | Biomet Spine, LLC | 2016 | 2 |
| +3 | K171495 | Zyston Strut Open Titanium Spacer System | Zimmer Biomet Spine, Inc. | 2018 | — |
| +4 | K251479 | Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion… | Mobarn Medical Devices, LLC | 2025 | — |
| +3 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081968 | Modification to LucentSummary page 4…n device (Product Code): MAX Device Panel – Regulation No.: Orthopedic – 21 CFR 888.3080 Primary Predicate: Spinal Elements Lucent K081968 Additional Predicates: Biomet Spine Fusion System K083815, Medtronic/AMT Wave K0… | 2008 |
| * | K083815 | Lanx Fusion SystemSummary page 4…ion No.: Orthopedic – 21 CFR 888.3080 Primary Predicate: Spinal Elements Lucent K081968 Additional Predicates: Biomet Spine Fusion System K083815, Medtronic/AMT Wave K083626, Globus Medical Caliber K102293… | 2009 |
| * | K083626 | Distractable Wave CageSummary page 4…Spinal Elements Lucent K081968 Additional Predicates: Biomet Spine Fusion System K083815, Medtronic/AMT Wave K083626, Globus Medical Caliber K102293… | 2009 |
| * | K102293 | Caliber SpacerSummary page 4…nt K081968 Additional Predicates: Biomet Spine Fusion System K083815, Medtronic/AMT Wave K083626, Globus Medical Caliber K102293 K142634 - Page 2 of 4 Device… | 2011 |
| * | K122967 | LucentSummary page 6…indications, technological characteristics, and principles of operation as the previously cleared Biomet Spine Fusion System (K083815), Spinal Elements Lucent (K081968, K122967), AMT, Inc./Medtronic Wave (K083626) and Globus Medical Caliber (K102293). The minor differences in the new components do not rai… | 2013 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151483 | Biomet Spine Fusion System | 2015 | 4 |
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 31 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 43 ancestors have a recall of any class.
- Of its descendants, K151483 (Biomet Spine, LLC, 2015) has gone furthest, with 4 descendants of its own.
- 11 other devices also cite its predicate K081968.
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. 2015, 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 (“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 contigtious 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…
Read the full statement (153 words)
When used as a lumbar intervertebral body fusion device, the Biomet Spine Fusion System (“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 contigtious 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/K142634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142634: 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/K142634
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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