510(k) · Cleared
ClearedEpic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Biomet Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 8, 2020 as substantially equivalent to K092765 (Lanx, Inc., 2010) and 3 other predicates after a 55-day review. Its family tree reaches back 6 generations to 2003.
- Decided
- Oct 8, 2020
- Review
- 55 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K032037 (2003). 40 ancestors in all, the oldest K761228 (1976). No later device cites it as a predicate yet.
- Root · 6 generations backK032037 CD Horizon (Addition of Spinous Process Plate)Medtronic Sofamor Danek · 2003
- 5 generations backK043053 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 4 generations backK071877 Lanx Spinal Fixation SystemLanx, LLC · 2007
- 3 generations backK100354 Primal OK Interspinous Fusion SystemOsteomed LP · 2010
- 2 generations backK121316 Lanx Spinal Fization SystemLanx, Inc. · 2012
- 1 generation backK131156 Lanx Spinal Fixation SystemLanx, Inc. · 2013
- This deviceK202309 Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty…Zimmer Biomet Spine, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K032037 | CD Horizon (Addition of Spinous Process Plate) | Medtronic Sofamor Danek | 2003 | — |
| −5 | K043053 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −4 | K071877 | Lanx Spinal Fixation System | Lanx, LLC | 2007 | — |
| −3 | K100354 | Primal OK Interspinous Fusion System | Osteomed LP | 2010 | — |
| −2 | K121316 | Lanx Spinal Fization System | Lanx, Inc. | 2012 | — |
| −1 | K131156 | Lanx Spinal Fixation System | Lanx, Inc. | 2013 | — |
| 0 (this device) | K202309 | Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation… | Zimmer Biomet Spine, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1976 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 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.
Planning a device in KWQ? 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? (4)
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 |
|---|---|---|---|
| * | K092765 | Lanx Anterior Plating SystemSummary page 10…Predicate FDA 510(k) (Common) Name (Common) Number Epic Epic K092765 Gallery Gallery K100805 Concero Concero… | 2010 |
| * | K100805 | Gallery Laminoplasty Fixation SystemSummary page 10…Number Epic Epic K092765 Gallery Gallery K100805 Concero Concero K101364 Alpine XC Alpine XC… | 2010 |
| * | K101364 | Lanx Facet Screw SystemSummary page 10…K092765 Gallery Gallery K100805 Concero Concero K101364 Alpine XC Alpine XC K131156 Aspen Aspen… | 2010 |
| * | K131156 | Lanx Spinal Fixation SystemSummary page 10…K100805 Concero Concero K101364 Alpine XC Alpine XC K131156 Aspen Aspen K131156 L-Plate L-Plate… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 40 ancestors have a recall of any class.
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. 2020, 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 Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic, lumbar, and/or sacral spine (T1-81) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities: * Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); * Spinal Stenosis…
Read the full statement (1,025 words)
The Epic Anterior Thoracolumbar Plate System is intended to provide fixation of the thoracic, lumbar, and/or sacral spine (T1-81) as an adjunct to fusion using autograft or allograft in skeletally mature patients in the treatment of the following instabilities or deformities:
* Degenerative Disc Disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
* Spinal Stenosis (indicated for L1-S1 only);
* Spondylolisthesis;
* Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis);
* Trauma (i.e., fracture, dislocation, or subluxation);
* Spondylolysis;
* Tumor;
* Pseudoarthrosis; and/or
* Failed previous fusion
The Epic Anterior Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach for fixation of the thoracic and thoracolumbar spine, or via the anterior surgical approach for fixation of the lumbosacral spine below the bifurcation of the great vessels.
The Gallery Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) after a laminoplasty has been performed. The Gallery Laminoplasty Fixation System holds or buttresses the allograft in place in order to prevent the allograft from expulsion or impinging on the spinal cord.
The Concero Facet Screw System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints, with or without bone graft, at single or multiple levels, from C2 to S1 for 3.5mm and 4.0mm screws and from L1 to S1 for 4.5mm screws. For transfacet fixation, the screws are inserted posteriorly through the superior side of the facet, across the facet joint, and into the pedicle. For translaminar facet fixation, the screws are inserted posteriorly through the lateral aspect of the spinous process, through the lamina, through the superior side of the facet, across the facet joint, and into the pedicle. The Concero Facet Screw System is indicated for treatment of any or all of the following:
* Pseudoarthrosis and failed previous fusions;
* Spondylolisthesis;
* Spondylolysis;
* Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies;
* Degeneration of the facets with instability and;
* Trauma including spinal fractures and/or dislocations.
The Zimmer Biomet Spine Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Alpine XC Adjustable MIS Fusion System is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Alpine XC Adjustable MIS Fusion System is intended for use with bone graft material, not intended for stand-alone use.
The Zimmer Biomet Spine Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The Aspen device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The Aspen device is intended for use with bone graft material, not intended for stand-alone use.
The Zimmer Biomet Spine Spinal Fixation System is intended to be used to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the thoracic, lumbar, and/or sacral spine. The system is intended for use with autograft or allograft.
The Zimmer Biomet Spine Spinal Fixation System is intended for posterior, non-cervical (T1-S2/ilium) pedicle and non-pedicle spinal fixation, to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following instabilities or deformities: degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; deformities or curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.
The LPlate device is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor. The LPlate device is intended for use with bone graft material, not intended for stand-alone use.
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/K202309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202309: Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202309
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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