510(k) · Cleared
ClearedATEC ALIF and LLIF Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 27, 2018 as substantially equivalent to K180480 (Alphatec Spine, Inc., 2018) and 9 other predicates after a 60-day review. Its family tree reaches back 23 generations to 1984. 1 of the 411 devices in its family, counting itself, has a Class I recall. 110 later devices descend from it.
- Decided
- Nov 27, 2018
- Review
- 60 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 23 generations to K841189 (1984). 300 ancestors in all. 110 later devices descend from it, 9 citing it directly. 1 of the 411 devices in this family, counting this one, has a Class I recall.
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 19 generations between
- 3 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- This deviceK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · cites it directly · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · cites it directly · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 69 of its ownK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 3 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 23 generations
- Root · 23 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 22 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 21 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 20 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 19 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 17 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 16 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 15 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 13 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 12 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 11 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 10 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 9 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 8 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 7 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 6 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 5 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 3 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 1 generation backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- This deviceK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
Showing 5 of 110 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer6 generations back · 2008
Most influential descendants
Showing 5 of 110 · See all- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · cites it directly99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · cites it directly78descendants
- K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019 · 2 generations on69descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 2 generations on67descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 3 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −22 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −21 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −20 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −19 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −17 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −16 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −15 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −13 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −12 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −11 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −10 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −9 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −8 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −7 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −6 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −5 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −1 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| 0 (this device) | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +1 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +1 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +3 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 11 | 0 |
| 2002 | 10 | 0 |
| 2003 | 16 | 0 |
| 2004 | 24 | 0 |
| 2005 | 20 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 41 | 1 |
| 2009 | 23 | 0 |
| 2010 | 16 | 0 |
| 2011 | 20 | 0 |
| 2012 | 12 | 0 |
| 2013 | 14 | 0 |
| 2014 | 14 | 0 |
| 2015 | 11 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 4 | 0 |
| 2020 | 10 | 0 |
| 2021 | 7 | 0 |
| 2022 | 12 | 0 |
| 2023 | 17 | 0 |
| 2024 | 18 | 0 |
| 2025 | 21 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K180480 | ATEC Universal Spacer SystemSummary page 4…. LEGALLY MARKETED PREDICATE DEVICES 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K180480 PHM, MAX ATEC Universal Spacer System Alphatec Spine Additional Predicate Devices K181453… | 2018 |
| * | K181453 | ATEC ALIF Spacer SystemSummary page 4…r Primary Predicate Device K180480 PHM, MAX ATEC Universal Spacer System Alphatec Spine Additional Predicate Devices K181453 PHM, MAX ATEC ALIF Spacer System Alphatec Spine K160958 PHM, MAX Battalion Univer… | 2018 |
| * | K160958 | Battalion Universal Spacer SystemSummary page 4…pacer System Alphatec Spine Additional Predicate Devices K181453 PHM, MAX ATEC ALIF Spacer System Alphatec Spine K160958 PHM, MAX Battalion Universal Spacer System Alphatec Spine K090782 MAX Novel ALIF Spina… | 2016 |
| * | K090782 | Novel Alif Spinal Spacer SystemSummary page 4…PHM, MAX ATEC ALIF Spacer System Alphatec Spine K160958 PHM, MAX Battalion Universal Spacer System Alphatec Spine K090782 MAX Novel ALIF Spinal Spacer System Alphatec Spine K143740 MAX Battalion Univer… | 2009 |
| * | K143740 | Battalion Universal Spacer SystemSummary page 4…PHM, MAX Battalion Universal Spacer System Alphatec Spine K090782 MAX Novel ALIF Spinal Spacer System Alphatec Spine K143740 MAX Battalion Universal Spacer System Alphatec Spine K101255 KWQ Anterior Lumbar… | 2015 |
| * | K101255 | Alphatec Spine Anterior Lumbar Plating SystemSummary page 4…MAX Novel ALIF Spinal Spacer System Alphatec Spine K143740 MAX Battalion Universal Spacer System Alphatec Spine K101255 KWQ Anterior Lumbar Plating System Alphatec Spine K163543 MAX, OVD Zimmer Biomet Fu… | 2010 |
| * | K163543 | Biomet Fusion SystemSummary page 4…MAX Battalion Universal Spacer System Alphatec Spine K101255 KWQ Anterior Lumbar Plating System Alphatec Spine K163543 MAX, OVD Zimmer Biomet Fusion System Zimmer Biomet K173892 MAX, PHM, OVD XLX Interbody Sys… | 2017 |
| * | K173892 | NuVasive® XLX Interbody SystemSummary page 4…KWQ Anterior Lumbar Plating System Alphatec Spine K163543 MAX, OVD Zimmer Biomet Fusion System Zimmer Biomet K173892 MAX, PHM, OVD XLX Interbody System NuVasive Inc. Zou® Anterior Lum… | 2018 |
| * | K121791 | Zou Anterior Lumbar Plate SystemSummary page 4…Biomet K173892 MAX, PHM, OVD XLX Interbody System NuVasive Inc. Zou® Anterior Lumber Plate K121791 KWQ CoreLink LLC System… | 2012 |
| * | K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemSummary page 4…CoreLink LLC System Solus Anterior Lumbar Interbody K102402 OVD Alphatec Spine Fusion System… | 2011 |
What descends from it? (110)
See all 1109 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183705 | IdentiTi Porous Ti Interbody System | 2019 | 99 |
| K191311 | ATEC Lateral Interbody System | 2019 | 78 |
| K203742 | IdentiTi ALIF Standalone Interbody System | 2021 | 59 |
| K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™… | 2022 | 28 |
| K192006 | SIRION Lateral Lumbar Interbody System | 2020 | 14 |
| K202495 | SIRION Lateral Lumbar Interbody Fusion | 2021 | 6 |
| K242364 | IdentiTi™ II Interbody System | 2024 | 4 |
| K251575 | IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody System | 2025 | 0 |
| K183092 | Kuros TLIF Cage | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K073202Ardis SpacerAbbott Spine, Inc. · 2008 · 6 generations back · ◆ in the 2008 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 34 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 36 of the 300 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K183705 (Alphatec Spine, Inc., 2019) has gone furthest, with 99 descendants of its own.
- 10 other devices also cite its predicate K180480.
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. 2018, 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 ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine. Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited…
Read the full statement (213 words)
The ATEC ALIF and LLIF Spacer System is indicated for spinal fusion procedures in skeletally mature patients at one or two contiguous levels in the thoracolumbar spine.
Thoracic: T1-T2 to T11-T12, or at the thoracolumbar junction (T12-L1), following discectomy for the treatment of a symptomatic degeneration disc disease (DDD), including thoracic disc herniation (myelopathy and/or radiculopathy with or without axial pain). The lateral approach is limited to levels T5-6 to T11-T12.
Lumbar: L1-L2 to L5-S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC ALIF and LLIF Spacer System is intended for use on patients who have had at least six months of non-operative treatment. It is intended for use with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft and supplemental fixation systems that are cleared by FDA for use in the thoracic and lumbar spine.
ATEC LLIF interbody implants with >20° lordosis must be used with the ATEC LLIF AMP integrated fixation in addition to supplemental fixation. ATEC ALIF interbody implants with >20° lordosis must be used with an anterior plate as the form of supplemental fixation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K182746 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182746: ATEC ALIF and LLIF 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/K182746
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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