510(k) · Cleared
ClearedATEC Lateral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 9, 2023 as substantially equivalent to K202624 (Zavation Medical Products, LLC, 2020) and 4 other predicates after a 55-day review. Its family tree reaches back 31 generations to 1984. 2 of the 1,026 devices in its family, counting itself, have a Class I recall.
- Decided
- May 9, 2023
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 31 generations to K841189 (1984). 1,025 ancestors in all, the oldest K781443 (1978). No later device cites it as a predicate yet. 2 of the 1,026 devices in this family, counting this one, have a Class I recall.
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 27 generations between
- 3 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 2 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 1 generation backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- This deviceK230721 ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023
Show all 31 generations
- Root · 31 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 30 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 29 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 28 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 27 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 26 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 25 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 24 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 23 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 22 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 21 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 20 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 19 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 18 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 17 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 16 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 15 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 14 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 13 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 12 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 11 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 10 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 9 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 8 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 7 generations backK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- 6 generations backK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
- 5 generations backK192938 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2019
- 4 generations backK203056 Invictus™ Spinal Fixation SystemAlphatec Spine, Inc. · 2020
- 3 generations backK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- 2 generations backK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- 1 generation backK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- This deviceK230721 ATEC Lateral Plate SystemAlphatec Spine, Inc. · 2023
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −31 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −30 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −29 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −28 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −27 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −26 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −25 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −24 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −23 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −22 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −21 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −20 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −19 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −18 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −17 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −16 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −15 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −14 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −13 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −12 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −11 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −10 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −9 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −8 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −7 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −6 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
| −5 | K192938 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2019 | — |
| −4 | K203056 | Invictus™ Spinal Fixation System | Alphatec Spine, Inc. | 2020 | — |
| −3 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| −2 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| −1 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| 0 (this device) | K230721 | ATEC Lateral Plate System | Alphatec Spine, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1992 | 10 | 0 |
| 1993 | 4 | 0 |
| 1994 | 8 | 0 |
| 1995 | 18 | 0 |
| 1996 | 16 | 0 |
| 1997 | 18 | 0 |
| 1998 | 25 | 0 |
| 1999 | 26 | 0 |
| 2000 | 37 | 0 |
| 2001 | 47 | 0 |
| 2002 | 41 | 0 |
| 2003 | 46 | 0 |
| 2004 | 69 | 0 |
| 2005 | 63 | 0 |
| 2006 | 49 | 0 |
| 2007 | 46 | 0 |
| 2008 | 88 | 1 |
| 2009 | 63 | 0 |
| 2010 | 55 | 1 |
| 2011 | 55 | 0 |
| 2012 | 30 | 0 |
| 2013 | 34 | 0 |
| 2014 | 39 | 0 |
| 2015 | 26 | 0 |
| 2016 | 20 | 0 |
| 2017 | 18 | 0 |
| 2018 | 14 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 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.
2 devices in this family have 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 KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K202624 | Z-Span Plate SystemSummary page 4…EGALLY MARKETED PREDICATE DEVICES 510(k) Product Code Trade Name Manufacturer Primary Predicate Device K202624 KWQ Z-Span Plate System Zavation Additional Predicate/Reference Devices… | 2020 |
| * | K092108 | Truss Thoracolumbar Plate SystemSummary page 4…-Span Plate System Zavation Additional Predicate/Reference Devices TRUSS™ Thoracolumbar Plate K092108 KWQ Globus System… | 2009 |
| * | K180166 | Life Spine Lumbar Fixation System (SENTRY)Summary page 4…Globus System Life Spine Lumbar Fixation System K180166 KWQ Life Spine (SENTRY®)… | 2018 |
| * | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation SystemSummary page 4…Life Spine (SENTRY®) PML, NKB, Invictus® Bone Cement, Invictus K221926 Alphatec Spine KWP, KWQ Spinal Fixation… | 2022 |
| * | K182808 | Aspida® Anterior Lumbar Plating SystemSummary page 4…Alphatec Spine KWP, KWQ Spinal Fixation System Aspida Anterior Lumbar Plating K182808 KWQ Alphatec Spine System IV.… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 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.
What does this lineage say?
- The line of descent spans 39 years and passes through 13 companies; a new generation was cleared every 8 months on median.
- 116 of the 1,025 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The ATEC Lateral Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LL1- S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative…
Read the full statement (106 words)
The ATEC Lateral Plate System is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (LL1- S1) spine instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous spine surgery.
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/K230721 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230721: ATEC Lateral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230721
Report an extraction error
Are you the manufacturer?
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