510(k) · Cleared
ClearedATEC Cervical Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Aug 21, 2018 as substantially equivalent to K171140 (Nexxt Spine, LLC, 2017) and 6 other predicates after an 81-day review. Its family tree reaches back 22 generations to 1984. 1 of the 455 devices in its family, counting itself, has a Class I recall. 100 later devices descend from it.
- Decided
- Aug 21, 2018
- Review
- 81 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 22 generations to K841189 (1984). 354 ancestors in all, the oldest K792352 (1979). 100 later devices descend from it, 2 citing it directly. 1 of the 455 devices in this family, counting this one, has a Class I recall.
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 18 generations between
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- This deviceK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · cites it directly · 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 · 2 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 4 generations on · 61 of its ownK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
Show all 22 generations
- Root · 22 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 20 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 19 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 18 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 17 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 16 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 15 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 14 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 13 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 12 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 11 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 10 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 9 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 8 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 7 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 6 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 5 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 4 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 3 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 2 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 1 generation backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- This deviceK181435 ATEC Cervical Spacer SystemAlphatec Spine, Inc. · 2018
Showing 5 of 100 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
Most influential descendants
Showing 5 of 100 · See all- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · cites it directly99descendants
- 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 · 2 generations on67descendants
- K203056Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020 · 4 generations on61descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −21 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −20 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −19 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −18 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −17 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −16 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −15 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −14 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −13 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −12 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −11 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −10 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −9 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −8 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −7 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −6 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −5 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −4 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −3 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| 0 (this device) | K181435 | ATEC Cervical Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +1 | 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 | — |
| +2 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +4 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 6 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 8 | 0 |
| 2001 | 14 | 0 |
| 2002 | 12 | 0 |
| 2003 | 18 | 0 |
| 2004 | 28 | 0 |
| 2005 | 17 | 0 |
| 2006 | 12 | 0 |
| 2007 | 17 | 0 |
| 2008 | 43 | 1 |
| 2009 | 25 | 0 |
| 2010 | 16 | 0 |
| 2011 | 22 | 0 |
| 2012 | 13 | 0 |
| 2013 | 17 | 0 |
| 2014 | 16 | 0 |
| 2015 | 9 | 0 |
| 2016 | 5 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 3 | 0 |
| 2020 | 9 | 0 |
| 2021 | 6 | 0 |
| 2022 | 12 | 0 |
| 2023 | 13 | 0 |
| 2024 | 16 | 0 |
| 2025 | 21 | 0 |
| 2026 | 20 | 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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 |
|---|---|---|---|
| * | K171140 | Matrixx SystemSummary page 4…ICES 510(k) Product Code Trade Name Manufacturer Primary Predicate Device ODP, MQP, K171140 MatrixxTM System Nexxt Spine MAX Additional Predicate De… | 2017 |
| * | K081730 | Novel Cervical Spinal Spacer SystemSummary page 4…ODP, MQP, K171140 MatrixxTM System Nexxt Spine MAX Additional Predicate Devices K081730 ODP Novel® Cervical Spinal Spacer Alphatec Spine System K… | 2008 |
| * | K180480 | ATEC Universal Spacer SystemSummary page 4…itional Predicate Devices K081730 ODP Novel® Cervical Spinal Spacer Alphatec Spine System K180480 MAX, PHM ATEC Universal Spacer System Alphatec Spine K150362 ODP CoRoent® Small I… | 2018 |
| * | K150362 | NuVasive CoRoent Small Interbody SystemSummary page 4…Alphatec Spine System K180480 MAX, PHM ATEC Universal Spacer System Alphatec Spine K150362 ODP CoRoent® Small Interbody System NuVasive K141376 ODP, MQP, HonourTM System… | 2015 |
| * | K141376 | Inertia Pedicle Screw System, Honour Spacer System, Facet Fixx, Struxxure Anterior…Summary page 4…MAX, PHM ATEC Universal Spacer System Alphatec Spine K150362 ODP CoRoent® Small Interbody System NuVasive K141376 ODP, MQP, HonourTM System Nexxt Spine MAX K120603… | 2014 |
| * | K120603 | Varilift -CSummary page 4…oRoent® Small Interbody System NuVasive K141376 ODP, MQP, HonourTM System Nexxt Spine MAX K120603 Wenzel Spine VariLift Cervical Wenzel Spine ODP… | 2013 |
| * | P980048 | Bak/Cervical (Bak/C) Interbody Fusion SystemSummary page 4…ODP Interbody Fusion Device ODP BAK/Cervical (BAK/C) Interbody Centerpulse Spine- P980048 Fusion System Tech Division… | 2001 |
What descends from it? (100)
See all 1002 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 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 10 months on median.
- 39 of the 354 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.
- 13 other devices also cite its predicate K171140.
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 0 | — | 0 | 0 |
| 2008 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The ATEC Cervical Spacer System is intended for spinal fusion procedures at one or two levels from C2 – T1 in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The ATEC Cervical Spacer System is intended for use with supplemental fixation systems and with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft. Patients should have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181435 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181435: ATEC Cervical Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181435
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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