510(k) · Cleared
ClearedinVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer Spine, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 20, 2015 as substantially equivalent to K122733 (Zimmer Spine, Inc., 2012) and 6 other predicates after an 88-day review. Its family tree reaches back 5 generations to 1992. 16 later devices descend from it.
- Decided
- Mar 20, 2015
- Review
- 88 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 5 generations to K922087 (1992). 21 ancestors in all. 16 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 4 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 3 generations backK013979 SC-Acufix Thinline Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2002 · Recalled
- 2 generations backK024326 Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate SystemSpinal Concepts, Inc. · 2003 · Recalled
- 1 generation backK052072 The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level…Abbott Spine, Inc. · 2005
- This deviceK143626 inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic…Zimmer Spine, Inc. · 2015
- Descendant · cites it directly · 13 of its ownK192481 AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020
- Descendant · 2 generations on · 10 of its ownK210035 ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical…Aegis Spine · 2021
- Descendant · 3 generations on · 6 of its ownK221050 ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation…Aegis Spine, Inc. · 2022
- Descendant · cites it directly · 3 of its ownK223719 Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK231839 CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate…L&K BIOMED Co., Ltd. · 2023
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K192481AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2020 · cites it directly13descendants
- K210035ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…Aegis Spine · 2021 · 2 generations on10descendants
- K221050ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…Aegis Spine, Inc. · 2022 · 3 generations on6descendants
- K223719Paeon Anterior Cervical Plate System, Elatus Lumbar Plate SystemAegis Spine, Inc. · 2023 · cites it directly3descendants
- K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd. · 2023 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −4 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −3 | K013979 | SC-Acufix Thinline Anterior Cervical Plate System | Spinal Concepts, Inc. | 2002 | 2 |
| −2 | K024326 | Spinal Concepts, Inc. Ant-Cer Dynamic Anterior Cervical Plate System | Spinal Concepts, Inc. | 2003 | 4 |
| −1 | K052072 | The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level Plates | Abbott Spine, Inc. | 2005 | — |
| 0 (this device) | K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical… | Zimmer Spine, Inc. | 2015 | — |
| +1 | K192481 | AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2020 | — |
| +2 | K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System… | Aegis Spine | 2021 | — |
| +3 | K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon… | Aegis Spine, Inc. | 2022 | — |
| +1 | K223719 | Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System | Aegis Spine, Inc. | 2023 | — |
| +2 | K231839 | CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System | L&K BIOMED Co., Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K122733 | V2F Anterior Fixation SystemSummary page 18…ode PMA Numbers V2F™ Anterior KWQ K122733 Class II Fixation System 21 CFR § 888.3060 Additional P… | 2012 |
| * | K111796 | Invizia Anterior Cervical Plate SystemSummary page 18…PMA Numbers ® inViZia Anterior KWQ K111796 Class II Cervical Plate System 21 CFR § 888.3060 SC-Acu… | 2011 |
| * | K052072 | The SC-Acufix Ant-Cer Dynamic Cervical Plate System Single Level PlatesSummary page 18…21 CFR § 888.3060 SC-AcuFix® Ant-Cer KWQ Dynamic Cervical K052072 Class II 21 CFR § 888.3060 Platin… | 2005 |
| * | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSummary page 18…21 CFR § 888.3060 Plating System SC-AcuFix® Slimline® KWQ Anterior Cervical Plate K990005 Class II 21 CFR § 888.3060 System SC-AcuFix® Thinline®… | 1999 |
| * | K013979 | SC-Acufix Thinline Anterior Cervical Plate SystemSummary page 18…Class II 21 CFR § 888.3060 System SC-AcuFix® Thinline® KWQ Anterior Cervical Plate K013979 Class II 21 CFR § 888.3060 System Trinica® Anterior… | 2002 |
| * | K140611 | Trinica Anterior Lumbar Plate SystemSummary page 18…Class II 21 CFR § 888.3060 System Trinica® Anterior KWQ K140611 Class II Lumbar Plate System 21 CFR § 888.3060 Trinic… | 2014 |
| * | K132012 | Trinica (R) Anterior Cervical Plate System, Trinica (R) Select Anterior Cervical Plate…Summary page 18…Trinica® Anterior Cervical Plate System KWQ Trinica® Select K132012 Class II 21 CFR § 888.3060 Anteri… | 2013 |
What descends from it? (16)
See all 164 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 23 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- 7 of the 21 ancestors have a recall of any class.
- Of its descendants, K192481 (L&K BIOMED Co., Ltd., 2020) has gone furthest, with 13 descendants of its own.
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. 2015, 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 inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1. The inViZia® Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and…
Read the full statement (602 words)
The inViZia® Anterior Cervical Plate System is designed for anterior interbody screw fixation of the cervical spine at levels C2-T1.
The inViZia® Anterior Cervical Plate System is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The SC-AcuFix® Ant-Cert Dynamic Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
The Spinal Concepts Inc. (SCI) Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
The SC-AcuFix® Thinline Anterior Cervical Plate System is indicated for use in the temporary stabilization of the cervical spine (C2-C7) during the development of solid spinal fusion inpatients with instability caused by the following: degenerative disc disease (as defined by neck pain of discogenic origin with denegation of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumor, spondylolisthesis, spinal stenosis, deformity (i.e. scoliosis, kyphosis, lordosis), pseudarthrosis, and failed previous fusions.
The Trinica® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels. This system is indicated in the treatment of lumbar or lumbosacral (L1-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 history and radiographic studies), pseudoarthrosis, spondylolisthesis, scoliosis, lordotic deformities of the spine, spinal stenosis, or a failed previous fusion. .
The Trinica® and Trinica® Select Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine at level C2-T1. The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis or scoliosis), pseudoarthrosis and/or failed previous fusions.
WARNING: These devices are not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
The V2F Anterior Fixation System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracic and thoracolumbar (T1-L5) 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), scoliosis, kyphosis, lordosis, 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/K143626 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143626: inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating System, SC-AcuFix Slimline Anterior Cervical Plate System, SC-AcuFix Thinline Anterior Cervical Plate System, Trinica Anterior Lumbar Plate System, Trinica and Trinica Select Anterior Cervical Plate System, V2F Anterior Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143626
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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