510(k) · Cleared
ClearedADIRA™ Lateral Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Globus Medical, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jan 25, 2024 as substantially equivalent to K120092 (Globus Medical, Inc., 2012) and 5 other predicates after a 64-day review. Its family tree reaches back 25 generations to 1984. 1 of the 675 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 25, 2024
- Review
- 64 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 25 generations to K841189 (1984). 674 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 1 of the 675 devices in this family, counting this one, has a Class I recall.
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 21 generations between
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- This deviceK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
Show all 25 generations
- Root · 25 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 24 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 23 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 22 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 21 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 20 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 19 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 18 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 17 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 16 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 15 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 14 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 13 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 12 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 11 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 10 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 9 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 8 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 7 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 6 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 5 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 4 generations backK172341 NuVasive® Modulus TLIF Interbody SystemNu Vasive, Incorporated · 2017
- 3 generations backK193593 NuVasive 3DP Interfixated ALIF SystemNu Vasive, Incorporated · 2020
- 2 generations backK201820 NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar…Nu Vasive, Incorporated · 2020
- 1 generation backK203278 INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT…Globus Medical, Inc. · 2021
- This deviceK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
Class I recalls in this family
- K073202 Ardis Spacer5 generations back · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −24 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −23 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −22 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −21 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −20 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −19 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −18 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −17 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −16 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −15 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −14 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −13 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −12 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −11 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −10 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −9 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −8 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −7 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −6 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −5 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −4 | K172341 | NuVasive® Modulus TLIF Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −3 | K193593 | NuVasive 3DP Interfixated ALIF System | Nu Vasive, Incorporated | 2020 | — |
| −2 | K201820 | NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System… | Nu Vasive, Incorporated | 2020 | — |
| −1 | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers… | Globus Medical, Inc. | 2021 | — |
| 0 (this device) | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 7 | 0 |
| 1993 | 6 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 11 | 0 |
| 1999 | 10 | 0 |
| 2000 | 23 | 0 |
| 2001 | 19 | 0 |
| 2002 | 19 | 0 |
| 2003 | 30 | 0 |
| 2004 | 54 | 0 |
| 2005 | 43 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 64 | 1 |
| 2009 | 42 | 0 |
| 2010 | 37 | 0 |
| 2011 | 37 | 0 |
| 2012 | 29 | 0 |
| 2013 | 34 | 0 |
| 2014 | 24 | 0 |
| 2015 | 21 | 0 |
| 2016 | 12 | 0 |
| 2017 | 12 | 0 |
| 2018 | 5 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 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 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? (6)
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 |
|---|---|---|---|
| * | K120092 | Plymouth Thoracolumbar Plate SystemSummary page 5…dy Fusion Device Product Code(s): KWQ, OVD Regulatory Class II, Panel Code: 87 Primary Predicate: PLYMOUTH™ Thoracolumbar Plate (K120092) Additional Predicates: PLYMOUTH™ Thoracolumbar Plate (K181846) InterContinental™ Plate-Spacer (K103… | 2012 |
| * | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Summary page 5…Regulatory Class II, Panel Code: 87 Primary Predicate: PLYMOUTH™ Thoracolumbar Plate (K120092) Additional Predicates: PLYMOUTH™ Thoracolumbar Plate (K181846) InterContinental™ Plate-Spacer (K103382, K203278) 4WEB Lateral Spine Truss System Platin… | 2018 |
| * | K103382 | Intercontinental Plate-SpacerSummary page 5…cate: PLYMOUTH™ Thoracolumbar Plate (K120092) Additional Predicates: PLYMOUTH™ Thoracolumbar Plate (K181846) InterContinental™ Plate-Spacer (K103382, K203278) 4WEB Lateral Spine Truss System Plating (K203065) ELSA™ Spacers (K161379, K2032… | 2011 |
| * | K203278 | INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental…Summary page 5…MOUTH™ Thoracolumbar Plate (K120092) Additional Predicates: PLYMOUTH™ Thoracolumbar Plate (K181846) InterContinental™ Plate-Spacer (K103382, K203278) 4WEB Lateral Spine Truss System Plating (K203065) ELSA™ Spacers (K161379, K203278) Refer… | 2021 |
| * | K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)Summary page 5…LYMOUTH™ Thoracolumbar Plate (K181846) InterContinental™ Plate-Spacer (K103382, K203278) 4WEB Lateral Spine Truss System Plating (K203065) ELSA™ Spacers (K161379, K203278) Reference Devices: NuVasive Thoracolumbar Interbody Systems: CoR… | 2021 |
| * | K161379 | ELSA SpacersSummary page 5…InterContinental™ Plate-Spacer (K103382, K203278) 4WEB Lateral Spine Truss System Plating (K203065) ELSA™ Spacers (K161379, K203278) Reference Devices: NuVasive Thoracolumbar Interbody Systems: CoRoent, Modulus XLIF, Cohe… | 2016 |
| † | K203714 | NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 40 years and passes through 13 companies; a new generation was cleared every 10 months on median.
- 75 of the 674 ancestors have a recall of any class; 1 has a Class I recall.
- 7 other devices also cite its predicate K120092.
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. 2024, 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?
ADIRA™ Lateral Plate System The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or…
Read the full statement (357 words)
ADIRA™ Lateral Plate System
The ADIRA™ 2-Hole and 4-Hole Plates, when used with screws only, are intended for use in the treatment of thoracolumbar (T1-L5) spinal instability as a result of fracture (including dislocation and subluxation), tumor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spinal surgery.
The ADIRA™ 1-Hole Plate is intended to stabilize allograft or autograft at one level (T1-L5), aiding in spinal fusion and to provide temporary stabilization and augment development of a spinal fusion. It may be used alone or with other anterior, lateral, anterolateral, or posterior spinal systems. The device is not intended for load bearing applications.
ADIRA™ Plate-Spacer Assemblies
ADIRA™ Plates may be assembled to a lateral lumbar interbody fusion device (HEDRON® L, TransContinental®, RISE®-L, Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers) to create a plate-spacer assembly. When assembled to HEDRON® L, TransContinental®, or RISE®-L Spacers, the plate-spacer assembly is indicated for use at one or more levels of the lumbosacral spine (L1-L5), as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. When ADIRA™ Plates are assembled to Modulus® XLIF, CoRoent®, or Cohere® XLIF Spacers, the plate-spacer assembly takes on the indications of the interbody device.
ADIRA™ Plate-Spacers are intended to be used with screws and/or anchors which accompany the implants. These devices are intended for use with supplemental fixation (e.g. facet screws or posterior fixation). In addition, the 2-Hole or 4-Hole Plate-Spacers are intended for stand-alone use in patients with DDD at one or two levels only when <20° lordotic implants are used with two or four screws, respectively.
ADIRA™ Plate-Spacers are to be filled with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233735 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233735: ADIRA™ Lateral Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233735
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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