510(k) · Cleared
ClearedUnify (R) Dynamic Anterior Cervical 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 Feb 20, 2014 as substantially equivalent to K121049 (Globus Medical, Inc., 2012) and 1 other predicate after a 92-day review. Its family tree reaches back 6 generations to 1993. 5 later devices descend from it.
- Decided
- Feb 20, 2014
- Review
- 92 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K926453 (1993). 18 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 5 generations backK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
- 4 generations backK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
- 3 generations backK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
- 2 generations backK092146 Xtend Anterior Cervical Plate SystemGlobus Medical, Inc. · 2009
- 1 generation backK121049 Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2012
- This deviceK133567 Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2014
- Descendant · cites it directly · 4 of its ownK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 3 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
- Descendant · 3 generations on · 0 of its ownK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · cites it directly4descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 3 generations on0descendants
- K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024 · 2 generations on0descendants
- K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −5 | K040721 | Assure Anterior Cervical Plate System | Globus Medical, Inc. | 2004 | — |
| −4 | K070775 | Modification to: Providence Anterior Cervical Plate System | Globus Medical, Inc. | 2007 | — |
| −3 | K081391 | Vip Anterior Cervical Plate System | Globus Medical, Inc. | 2008 | — |
| −2 | K092146 | Xtend Anterior Cervical Plate System | Globus Medical, Inc. | 2009 | — |
| −1 | K121049 | Unify Dynamic Anterior Cervical Plate System | Globus Medical, Inc. | 2012 | — |
| 0 (this device) | K133567 | Unify (R) Dynamic Anterior Cervical Plate System | Globus Medical, Inc. | 2014 | — |
| +1 | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +3 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +2 | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
| +3 | K211205 | Prase-C Anterior Cervical Plate System | Gbs Commonwealth Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K121049 | Unify Dynamic Anterior Cervical Plate SystemSummary page 1…rthosis Product Code: KWVQ Regulatory Class 11,Panel Code 87. Predicate(s): UNIFY® Dynamic Anterior Cervical Plate System (K1 21049) ASSURE Anterior Cervical Plate System (K040721) Purpose: The purpose of this submission is to request cleara… | 2012 |
| * | K040721 | Assure Anterior Cervical Plate SystemSummary page 1…gulatory Class 11,Panel Code 87. Predicate(s): UNIFY® Dynamic Anterior Cervical Plate System (K1 21049) ASSURE Anterior Cervical Plate System (K040721) Purpose: The purpose of this submission is to request clearance for additional UNIFY® screws to be used with ASSURE® and UNIFY®… | 2004 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP… | 2018 | 4 |
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 21 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 18 ancestors have a recall of any class.
- Of its descendants, K181846 (Globus Medical, Inc., 2018) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K121049.
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. 2014, 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 UNIFY® Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications; 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 (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and…
Read the full statement (125 words)
The UNIFY® Dynamic Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-C7) for the following indications; 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 (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
The ASSURE® Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine C2-C7 for the following indications: 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), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133567: Unify (R) Dynamic Anterior Cervical 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/K133567
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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