510(k) · Cleared
ClearedBiomet Lateral Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet Spine (Aka Ebi, LLC) · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Oct 24, 2012 as substantially equivalent to K082406 (Ebi, L.P., 2009) and 11 other predicates after a 28-day review. Its family tree reaches back 12 generations to 1984. 171 later devices descend from it.
- Decided
- Oct 24, 2012
- Review
- 28 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 12
Its longest line of descent runs back 12 generations to K841189 (1984). 77 ancestors in all. 171 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 8 generations between
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012
- Descendant · cites it directly · 169 of its ownK151310 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 2 generations on · 166 of its ownK160924 Amendia Interbody Fusion DevicesAmendia, Inc. · 2016
- Descendant · 3 generations on · 129 of its ownK171496 Tritanium C Anterior Cervical CageStryker Spine · 2017
- Descendant · 4 generations on · 106 of its ownK180364 HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018
- Descendant · 5 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 12 generations
- Root · 12 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 11 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 10 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 9 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 8 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 6 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 5 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 4 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 2 generations backK090353 Perimeter Interbody Fusion DeviceMedtronic Sofamor Danek · 2009
- 1 generation backK113528 Clydesdale (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- This deviceK122989 Biomet Lateral Spacer SystemBiomet Spine (Aka Ebi, LLC) · 2012
Showing 5 of 171 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 171 · See all- K151310Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · cites it directly169descendants
- K160924Amendia Interbody Fusion DevicesAmendia, Inc. · 2016 · 2 generations on166descendants
- K171496Tritanium C Anterior Cervical CageStryker Spine · 2017 · 3 generations on129descendants
- K180364HD LifeSciences Cervical IBFD SystemHd Lifesciences, LLC · 2018 · 4 generations on106descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 5 generations on104descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −11 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −10 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −9 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −8 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −6 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −5 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −4 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −2 | K090353 | Perimeter Interbody Fusion Device | Medtronic Sofamor Danek | 2009 | — |
| −1 | K113528 | Clydesdale (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| 0 (this device) | K122989 | Biomet Lateral Spacer System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| +1 | K151310 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +2 | K160924 | Amendia Interbody Fusion Devices | Amendia, Inc. | 2016 | — |
| +3 | K171496 | Tritanium C Anterior Cervical Cage | Stryker Spine | 2017 | — |
| +4 | K180364 | HD LifeSciences Cervical IBFD System | Hd Lifesciences, LLC | 2018 | — |
| +5 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 8 | 0 |
| 2004 | 9 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 4 | 0 |
| 2019 | 12 | 0 |
| 2020 | 12 | 0 |
| 2021 | 13 | 0 |
| 2022 | 16 | 0 |
| 2023 | 22 | 0 |
| 2024 | 29 | 0 |
| 2025 | 29 | 0 |
| 2026 | 28 | 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? (12)
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 |
|---|---|---|---|
| * | K082406 | Expandable Peek-Optima ImplantSummary page 2…d sizing) of the Biomet Lateral Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Expandable PEEK Implant (K082406, K040928) " ESL Spacer (K092574, K040482) * Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI… | 2009 |
| * | K040928 | Expandable Peek VBR ImplantSummary page 2…of the Biomet Lateral Spacer System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Expandable PEEK Implant (K082406, K040928) " ESL Spacer (K092574, K040482) * Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI 10650)… | 2004 |
| * | K092574 | Esl Spinal SystemSummary page 2…er System is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Expandable PEEK Implant (K082406, K040928) " ESL Spacer (K092574, K040482) * Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI 10650) * Medtronic Clydesdale S… | 2010 |
| * | K040482 | Ebi Esl Spine Spacer SystemSummary page 2…is the same as, or similar to, the predicate devices. Examples of predicate devices include: * Expandable PEEK Implant (K082406, K040928) " ESL Spacer (K092574, K040482) * Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI 10650) * Medtronic Clydesdale Spacer (K0… | 2004 |
| * | K112014 | Zyston Straight Spacer System | 2011 |
| * | K110650 | Zyston Arc Interbody Spacer | 2011 |
| * | K083026 | Clydesdale Spinal SystemSummary page 2…040928) " ESL Spacer (K092574, K040482) * Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI 10650) * Medtronic Clydesdale Spacer (K083026, KI 113528) * NuVasive CoRoent (K071795) * Synthes Spine Oracle Spacer (K072791) * DePuy Lateral Spacer (K0821 28, K0… | 2008 |
| * | K113528 | Clydesdale (R) Spinal SystemSummary page 2…" ESL Spacer (K092574, K040482) * Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI 10650) * Medtronic Clydesdale Spacer (K083026, KI 113528) * NuVasive CoRoent (K071795) * Synthes Spine Oracle Spacer (K072791) * DePuy Lateral Spacer (K0821 28, K090899) Per… | 2011 |
| * | K071795 | Nuvasive Coroent SystemSummary page 2…* Zyston Straight Spacer System (KI 12014) * Zyston Curve Spacer System (KI 10650) * Medtronic Clydesdale Spacer (K083026, KI 113528) * NuVasive CoRoent (K071795) * Synthes Spine Oracle Spacer (K072791) * DePuy Lateral Spacer (K0821 28, K090899) Performance Data Mechanical testing… | 2007 |
| * | K072791 | Oracle Spacer, Opal SpacerSummary page 2…4) * Zyston Curve Spacer System (KI 10650) * Medtronic Clydesdale Spacer (K083026, KI 113528) * NuVasive CoRoent (K071795) * Synthes Spine Oracle Spacer (K072791) * DePuy Lateral Spacer (K0821 28, K090899) Performance Data Mechanical testing recommended in the special controls guidance… | 2007 |
| * | K082128 | Depuy Spine Lateral Cage SystemSummary page 2…KI 10650) * Medtronic Clydesdale Spacer (K083026, KI 113528) * NuVasive CoRoent (K071795) * Synthes Spine Oracle Spacer (K072791) * DePuy Lateral Spacer (K0821 28, K090899) Performance Data Mechanical testing recommended in the special controls guidance document entitled "Class 11 Special C… | 2008 |
| * | K090899 | Depuy Spine Lateral SystemSummary page 2…* Medtronic Clydesdale Spacer (K083026, KI 113528) * NuVasive CoRoent (K071795) * Synthes Spine Oracle Spacer (K072791) * DePuy Lateral Spacer (K0821 28, K090899) Performance Data Mechanical testing recommended in the special controls guidance document entitled "Class 11 Special Controls G… | 2009 |
What descends from it? (171)
See all 1712 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 1.4 years on median.
- 8 of the 77 ancestors have a recall of any class.
- Of its descendants, K151310 (Amendia, Inc., 2016) has gone furthest, with 169 descendants of its own.
- 6 other devices also cite its predicate K082406.
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?
The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement 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…
Read the full statement (296 words)
The Biomet Lateral Spacer System is indicated for vertebral body replacement and intervertebral body fusion. When used for vertebral body replacement, the Biomet Lateral Spacer System is indicated for use in the thoracolumbar spine (i.e., TI- L5) for partial replacement 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 Lateral Spacer System is also indicated for treating fractures of the thoracic and lumbar spine. The Biomet Lateral Spacer System is designed to restore the biomnechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period of time. When used for vertebral body replacement, the Biomet Lateral Spacer System is designed for use with bone graft and is intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
As an intervertebral body fusion device, the Biomet Lateral Spacer System is indicated for intervertebral body fusion at one level or two contiguous levels in the lumbar spine from L2 to SI in patients with degenerative disc-disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. When used as an intervertebral body fusion device, the Biomet Lateral Spacer System is designed for use with autograft to facilitate fusion and is intended for use with supplemental fixation systems cleared for use in the lumbar spine. The Biomet Lateral Spacer System may be implanted via an open or minimally invasive lateral approach.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K122989: Biomet Lateral Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K122989
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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