510(k) · Cleared
ClearedBiomet Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Cleared on Feb 28, 2017 as substantially equivalent to K141791 (Biomet Spine, 2014) after a 74-day review. Its family tree reaches back 11 generations to 1984. 124 later devices descend from it.
- Decided
- Feb 28, 2017
- Review
- 74 days
- Class
- Class II
- Product code
- OVD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K841189 (1984). 24 ancestors in all. 124 later devices descend from it, 6 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK123767 Lanx Fusion System- SALanx, Inc. · 2013 · Recalled
- 2 generations backK131547 Lanx Fusion SystemLanx, Inc. · 2013 · Recalled
- 1 generation backK141791 Biomet Fusion SystemBiomet Spine · 2014
- This deviceK163543 Biomet Fusion SystemZimmer Biomet Spine, Inc. · 2017
- Descendant · cites it directly · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 3 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
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 backK020887 Ebi Ais Spine SystemEbi, L.P. · 2002
- 8 generations backK040482 Ebi Esl Spine Spacer SystemEbi, L.P. · 2004
- 7 generations backK042268 Ebi Cas Spine Spacer SystemEbi, L.P. · 2004
- 6 generations backK052384 Lanx VBR SystemLanx, LLC · 2005
- 5 generations backK083815 Lanx Fusion SystemLanx, Inc. · 2009
- 4 generations backK102738 Lanx Fusion SystemLanx, LLC · 2011 · Recalled
- 3 generations backK123767 Lanx Fusion System- SALanx, Inc. · 2013 · Recalled
- 2 generations backK131547 Lanx Fusion SystemLanx, Inc. · 2013 · Recalled
- 1 generation backK141791 Biomet Fusion SystemBiomet Spine · 2014
- This deviceK163543 Biomet Fusion SystemZimmer Biomet Spine, Inc. · 2017
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly110descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 3 generations on69descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 3 generations on67descendants
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 | K020887 | Ebi Ais Spine System | Ebi, L.P. | 2002 | — |
| −8 | K040482 | Ebi Esl Spine Spacer System | Ebi, L.P. | 2004 | — |
| −7 | K042268 | Ebi Cas Spine Spacer System | Ebi, L.P. | 2004 | — |
| −6 | K052384 | Lanx VBR System | Lanx, LLC | 2005 | — |
| −5 | K083815 | Lanx Fusion System | Lanx, Inc. | 2009 | — |
| −4 | K102738 | Lanx Fusion System | Lanx, LLC | 2011 | 1 |
| −3 | K123767 | Lanx Fusion System- SA | Lanx, Inc. | 2013 | 4 |
| −2 | K131547 | Lanx Fusion System | Lanx, Inc. | 2013 | 1 |
| −1 | K141791 | Biomet Fusion System | Biomet Spine | 2014 | — |
| 0 (this device) | K163543 | Biomet Fusion System | Zimmer Biomet Spine, Inc. | 2017 | — |
| +1 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +3 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 13 | 0 |
| 2021 | 7 | 0 |
| 2022 | 13 | 0 |
| 2023 | 18 | 0 |
| 2024 | 20 | 0 |
| 2025 | 22 | 0 |
| 2026 | 21 | 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 OVD? 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 OVD device
- #1 K222009 aprevo® anterior lumbar interbody fusion…score 26.0 · 23 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 |
|---|---|---|---|
| * | K141791 | Biomet Fusion SystemSummary page 5…odes: MAX, MQP, ODP Device Panel – Regulation No.: Orthopedic – 21 CFR 888.3080 and/or 888.3060 Primary Predicate: Biomet Fusion System K141791 K163543 - Page 2 of 4 Biomet Spine Special 510(k) P… | 2014 |
What descends from it? (124)
See all 1246 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182746 | ATEC ALIF and LLIF Spacer System | 2018 | 110 |
| K192006 | SIRION Lateral Lumbar Interbody System | 2020 | 14 |
| K192492 | EL CAPITAN Anterior Lumber Interbody System | 2020 | 10 |
| K163670 | Rampart One Lumbar Interbody Fusion Device | 2017 | 3 |
| K192687 | TrellOss™-L MPF | 2020 | 1 |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | 2019 | 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 33 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 5 of the 24 ancestors have a recall of any class.
- Of its descendants, K182746 (Alphatec Spine, Inc., 2018) has gone furthest, with 110 descendants of its own.
- 3 other devices also cite its predicate K141791.
How does its category compare?
All OVD devicesOVD Intervertebral Fusion Device With Integrated Fixation, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OVD
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVD
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVD
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVD
50in 2025
MAUDE reports naming product code OVD, 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 | 2 | — | 0 | 0 |
| 2008 | 8 | 84 | 0 | 0 |
| 2009 | 3 | 152 | 0 | 2 |
| 2010 | 8 | 117 | 0 | 2 |
| 2011 | 9 | 167 | 0 | 6 |
| 2012 | 10 | 78 | 0 | 16 |
| 2013 | 11 | 137 | 4 | 17 |
| 2014 | 14 | 139 | 0 | 35 |
| 2015 | 12 | 166 | 0 | 43 |
| 2016 | 13 | 127 | 1 | 55 |
| 2017 | 12 | 127 | 0 | 72 |
| 2018 | 14 | 126 | 0 | 112 |
| 2019 | 12 | 91 | 0 | 171 |
| 2020 | 14 | 91 | 0 | 203 |
| 2021 | 7 | 108 | 1 | 221 |
| 2022 | 14 | 133 | 1 | 74 |
| 2023 | 12 | 92 | 0 | 67 |
| 2024 | 12 | 110 | 0 | 92 |
| 2025 | 10 | 100 | 1 | 50 |
| 2026 | 8 | 93 | 1 | — |
What is it indicated for?
When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System (“Biomet 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 spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (475 words)
When used as a cervical intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System (“Biomet 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 spinal level from the C2-C3 disc to the C7-T1 disc. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should have had at least six weeks of non-operative treatment. The Biomet Cervical Intervertebral Body Fusion System is to be implanted via an anterior approach and is to be combined with supplemental fixation. Approved supplemental fixation systems include the Biomet Anterior Cervical Plate System.
When used as a lumbar intervertebral body fusion device, the Biomet Intervertebral Body/VBR Fusion System (“Biomet 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). Implants with 14 degree lordosis or greater are only indicated from levels L2-L5 and are to be used with at least one integrated fixation screw. The Biomet Fusion System is to be combined with supplemental fixation (except as noted below). Approved supplemental fixation systems include the Biomet Spinal Fixation System. The Biomet SA standalone interbody implants, when implanted via an anterior approach and used with the integrated fixation screws, do not require use of supplement fixation.
When used as vertebral body replacement, the Biomet Intervertebral Body/VBR Fusion System (“Biomet Fusion System”) is indicated for use to replace a vertebral body that has been resected or excised due to tumor or trauma/fracture. The device is intended for use as a vertebral body replacement in the thoracolumbar spine (from T1 to L5) The Biomet Vertebral Body Replacement System may also be used in the thoracolumbar spine (i.e. T1- L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body resected or excised for the treatment of tumors in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Biomet Vertebral Body Replacement System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Vertebral Body Replacement System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column. For either indication the system must be used with supplemental internal fixation. Supplemental internal fixation is required to properly utilize this system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K163543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163543: Biomet 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/K163543
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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