510(k) · Cleared
ClearedAlcantara Thoracolumbar Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Camber Spine Technologies, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Apr 16, 2024 as substantially equivalent to K171538 (Meditech Spine, LLC, 2017) and 8 other predicates after a 263-day review. Its family tree reaches back 27 generations to 1984. 1 of the 723 devices in its family, counting itself, has a Class I recall.
- Decided
- Apr 16, 2024
- Review
- 263 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 27 generations to K841189 (1984). 722 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet. 1 of the 723 devices in this family, counting this one, has a Class I recall.
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 23 generations between
- 3 generations backK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- 2 generations backK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
- 1 generation backK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- This deviceK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
Show all 27 generations
- Root · 27 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 26 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 25 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 24 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 23 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 22 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 21 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 20 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 19 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 18 generations backK073291 Capstone Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2008
- 17 generations backK094025 Crescent Spinal SystemMedtronic Sofamor Danek · 2010
- 16 generations backK110543 Crescent (R) Spinal System TitaniumMedtronic Sofamor Danek USA, Inc. · 2011
- 15 generations backK121683 Acculif TL CageCoalign Innovations, Inc. · 2012
- 14 generations backK123752 Acculif TL and PL CageCoalign Innovations, Inc. · 2013
- 13 generations backK132505 Acculif TL and PL CageCoalign Innovations, Inc. · 2013 · Recalled
- 12 generations backK141217 Acculif TL and PL CageStryker Corporation · 2014 · Recalled
- 11 generations backK143163 AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers…Stryker Corporation · 2015
- 10 generations backK153782 NuVasive® Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 9 generations backK161230 NuVasive Lumbar Interbody ImplantsNu Vasive, Incorporated · 2016
- 8 generations backK170962 NuVasive® CoRoent® Thoracolumbar SystemNu Vasive, Incorporated · 2017
- 7 generations backK171633 NuVasive TLX Interbody SystemNu Vasive, Incorporated · 2017
- 6 generations backK180480 ATEC Universal Spacer SystemAlphatec Spine, Inc. · 2018
- 5 generations backK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- 4 generations backK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- 3 generations backK192006 SIRION Lateral Lumbar Interbody SystemAstura Medical, LLC · 2020
- 2 generations backK202495 SIRION Lateral Lumbar Interbody FusionAstura Medical, LLC · 2021
- 1 generation backK231743 F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody…Corelink, LLC · 2023
- This deviceK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 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 |
|---|---|---|---|---|---|
| −27 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −26 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −25 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −24 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −23 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −22 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −21 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −20 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −19 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −18 | K073291 | Capstone Spinal System | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −17 | K094025 | Crescent Spinal System | Medtronic Sofamor Danek | 2010 | — |
| −16 | K110543 | Crescent (R) Spinal System Titanium | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −15 | K121683 | Acculif TL Cage | Coalign Innovations, Inc. | 2012 | — |
| −14 | K123752 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | — |
| −13 | K132505 | Acculif TL and PL Cage | Coalign Innovations, Inc. | 2013 | 3 |
| −12 | K141217 | Acculif TL and PL Cage | Stryker Corporation | 2014 | 3 |
| −11 | K143163 | AVS® AL and ALign PEEK Spacers, AVS® PL and UniLIF PEEK Spacers, AVS® TL PEEK… | Stryker Corporation | 2015 | — |
| −10 | K153782 | NuVasive® Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −9 | K161230 | NuVasive Lumbar Interbody Implants | Nu Vasive, Incorporated | 2016 | — |
| −8 | K170962 | NuVasive® CoRoent® Thoracolumbar System | Nu Vasive, Incorporated | 2017 | — |
| −7 | K171633 | NuVasive TLX Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −6 | K180480 | ATEC Universal Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −5 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −4 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| −3 | K192006 | SIRION Lateral Lumbar Interbody System | Astura Medical, LLC | 2020 | — |
| −2 | K202495 | SIRION Lateral Lumbar Interbody Fusion | Astura Medical, LLC | 2021 | — |
| −1 | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and… | Corelink, LLC | 2023 | — |
| 0 (this device) | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 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 | 9 | 0 |
| 1997 | 14 | 0 |
| 1998 | 10 | 0 |
| 1999 | 10 | 0 |
| 2000 | 21 | 0 |
| 2001 | 20 | 0 |
| 2002 | 24 | 0 |
| 2003 | 32 | 0 |
| 2004 | 46 | 0 |
| 2005 | 43 | 0 |
| 2006 | 28 | 0 |
| 2007 | 32 | 0 |
| 2008 | 68 | 1 |
| 2009 | 47 | 0 |
| 2010 | 41 | 0 |
| 2011 | 41 | 0 |
| 2012 | 32 | 0 |
| 2013 | 40 | 0 |
| 2014 | 32 | 0 |
| 2015 | 25 | 0 |
| 2016 | 14 | 0 |
| 2017 | 16 | 0 |
| 2018 | 7 | 0 |
| 2019 | 7 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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? (9)
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 |
|---|---|---|---|
| * | K171538 | Cure™ Lumbar Plate SystemSummary page 5…subject Alcantara Thoracolumbar Plate System is substantially equivalent to the following predicate devices: Primary Predicate: Meditech Spine Cure™ Lumbar Plate – K171538 Additional Predicates: Choice Spine Raven Lumbar Plate System – K183214 Precision Spine Accufit – K162211, K220324… | 2017 |
| * | K183214 | Raven Lumbar Plate SystemSummary page 5…e following predicate devices: Primary Predicate: Meditech Spine Cure™ Lumbar Plate – K171538 Additional Predicates: Choice Spine Raven Lumbar Plate System – K183214 Precision Spine Accufit – K162211, K220324 Stryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral P… | 2019 |
| * | K162211 | AccuFit Lateral Plate SystemSummary page 5…redicate: Meditech Spine Cure™ Lumbar Plate – K171538 Additional Predicates: Choice Spine Raven Lumbar Plate System – K183214 Precision Spine Accufit – K162211, K220324 Stryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral Plate System – K231743 Camber Spine… | 2016 |
| * | K220324 | AccuFit Lateral 2-Hole PlateSummary page 5… Meditech Spine Cure™ Lumbar Plate – K171538 Additional Predicates: Choice Spine Raven Lumbar Plate System – K183214 Precision Spine Accufit – K162211, K220324 Stryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral Plate System – K231743 Camber Spine Technolo… | 2022 |
| * | K142699 | LITe Plate SystemSummary page 5…K171538 Additional Predicates: Choice Spine Raven Lumbar Plate System – K183214 Precision Spine Accufit – K162211, K220324 Stryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral Plate System – K231743 Camber Spine Technologies FORTICO Anterior Cervical Fixation Sy… | 2014 |
| * | K150449 | LITe Plate SystemSummary page 5…Additional Predicates: Choice Spine Raven Lumbar Plate System – K183214 Precision Spine Accufit – K162211, K220324 Stryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral Plate System – K231743 Camber Spine Technologies FORTICO Anterior Cervical Fixation System – K1… | 2015 |
| * | K231743 | F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro… Cleared while this submission was under review Summary page 5…bar Plate System – K183214 Precision Spine Accufit – K162211, K220324 Stryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral Plate System – K231743 Camber Spine Technologies FORTICO Anterior Cervical Fixation System – K191584 Camber Spine Technologies SPIRA-T Obliq… | 2023 |
| * | K191584 | FORTICO Anterior Cervical Fixation SystemSummary page 5…ryer LITe® Plate System – K142699, K150449 Corelink, Oro Lateral Plate System – K231743 Camber Spine Technologies FORTICO Anterior Cervical Fixation System – K191584 Camber Spine Technologies SPIRA-T Oblique Posterior Lumbar Spacers – K210595 The subject Alcantara Thoracolumbar Plate Sys… | 2019 |
| * | K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersSummary page 5…– K231743 Camber Spine Technologies FORTICO Anterior Cervical Fixation System – K191584 Camber Spine Technologies SPIRA-T Oblique Posterior Lumbar Spacers – K210595 The subject Alcantara Thoracolumbar Plate System is similar to the predicate devices. The indications for use and geometry of th… | 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 16 companies; a new generation was cleared every 9 months on median.
- 78 of the 722 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K171538.
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?
The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 and 4-screw plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in…
Read the full statement (198 words)
The Camber Spine Alcantara Thoracolumbar Plate System 2, 3 and 4-screw plates are indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the thoracic and thoracolumbar (T1-L5) spine or via an anterior approach below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine. The system is intended to provide additional support during fusion in skeletally mature patients in the treatment of the following acute and chronic instabilities or deformities: 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; Spinal stenosis; Tumors; Trauma (i.e. Fractures including dislocation and subluxation) Deformities (i.e. Scoliosis, Kyphosis or Lordosis); Failed Previous Fusion.
The Camber Spine Alcantara Thoracolumbar Plate System Buttress Plate is intended to stabilize the allograft or autograft at one level (T1-S1) as an aid to spinal fusion and to provide temporary stabilization and augment development of a solid spinal fusion. It may be used alone or with other anterior, anterolateral, or posterior spinal systems made of compatible materials. This device is not intended for load bearing applications.
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/K232256 · printed Nov 3, 2026
Cite this page
510(k) Report. “K232256: Alcantara Thoracolumbar Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K232256
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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