510(k) · Cleared
ClearedUnify 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 Jun 27, 2012 as substantially equivalent to K040721 (Globus Medical, Inc., 2004) and 4 other predicates after an 82-day review. Its family tree reaches back 5 generations to 1993. 10 later devices descend from it.
- Decided
- Jun 27, 2012
- Review
- 82 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K926453 (1993). 17 ancestors in all. 10 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK926453 Synthes (U.S.a.) Anterior Cervical Vertebrae PlateSynthes (Usa) · 1993
- 4 generations backK040721 Assure Anterior Cervical Plate SystemGlobus Medical, Inc. · 2004
- 3 generations backK070775 Modification to: Providence Anterior Cervical Plate SystemGlobus Medical, Inc. · 2007
- 2 generations backK081391 Vip Anterior Cervical Plate SystemGlobus Medical, Inc. · 2008
- 1 generation backK092146 Xtend Anterior Cervical Plate SystemGlobus Medical, Inc. · 2009
- This deviceK121049 Unify Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 5 of its ownK133567 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 · cites it directly · 3 of its ownK192314 RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019
- Descendant · 2 generations on · 2 of its ownK231251 FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024
- Descendant · 2 generations on · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K133567Unify (R) Dynamic Anterior Cervical Plate SystemGlobus Medical, Inc. · 2014 · cites it directly5descendants
- K181846ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP…Globus Medical, Inc. · 2018 · cites it directly4descendants
- K192314RESONATE Anterior Cervical Plate SystemGlobus Medical, Inc. · 2019 · cites it directly3descendants
- K231251FlexWing Anterior Cervical Plate SystemJeil Medical Corporation · 2024 · 2 generations on2descendants
- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K926453 | Synthes (U.S.a.) Anterior Cervical Vertebrae Plate | Synthes (Usa) | 1993 | — |
| −4 | K040721 | Assure Anterior Cervical Plate System | Globus Medical, Inc. | 2004 | — |
| −3 | K070775 | Modification to: Providence Anterior Cervical Plate System | Globus Medical, Inc. | 2007 | — |
| −2 | K081391 | Vip Anterior Cervical Plate System | Globus Medical, Inc. | 2008 | — |
| −1 | K092146 | Xtend Anterior Cervical Plate System | Globus Medical, Inc. | 2009 | — |
| 0 (this device) | K121049 | Unify Dynamic Anterior Cervical Plate System | Globus Medical, Inc. | 2012 | — |
| +1 | 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 | — |
| +1 | K192314 | RESONATE Anterior Cervical Plate System | Globus Medical, Inc. | 2019 | — |
| +2 | K231251 | FlexWing Anterior Cervical Plate System | Jeil Medical Corporation | 2024 | — |
| +2 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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? (5)
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 |
|---|---|---|---|
| * | K040721 | Assure Anterior Cervical Plate SystemSummary page 1…rvertebral Body Fixation Orthosis Product Code: KWQ Regulatory Class: 11,Panel Code: 87 Predicate(s): ASSURE® Anterior Cervical Plate (K040721) PROVIDENCE® Anterior Cervical Plate (K070775) XTEND®Anterior Cervical Plate (K092146)… | 2004 |
| * | K070775 | Modification to: Providence Anterior Cervical Plate SystemSummary page 1…: KWQ Regulatory Class: 11,Panel Code: 87 Predicate(s): ASSURE® Anterior Cervical Plate (K040721) PROVIDENCE® Anterior Cervical Plate (K070775) XTEND®Anterior Cervical Plate (K092146) Medtronic ATLANTIS® Anterior Cervical Plate (K0631 00)… | 2007 |
| * | K092146 | Xtend Anterior Cervical Plate SystemSummary page 1…7 Predicate(s): ASSURE® Anterior Cervical Plate (K040721) PROVIDENCE® Anterior Cervical Plate (K070775) XTEND®Anterior Cervical Plate (K092146) Medtronic ATLANTIS® Anterior Cervical Plate (K0631 00) Synthes Vectram Anterior Cervical Plate (… | 2009 |
| * | K063100 | Atlantis Anterior Cervical Plate System, Translational PlateSummary page 1…PROVIDENCE® Anterior Cervical Plate (K070775) XTEND®Anterior Cervical Plate (K092146) Medtronic ATLANTIS® Anterior Cervical Plate (K0631 00) Synthes Vectram Anterior Cervical Plate (K051665) Purpose: The purpose of this submission is to request clearan… | 2007 |
| * | K051665 | Synthes Vectra-T SystemSummary page 1…XTEND®Anterior Cervical Plate (K092146) Medtronic ATLANTIS® Anterior Cervical Plate (K0631 00) Synthes Vectram Anterior Cervical Plate (K051665) Purpose: The purpose of this submission is to request clearance for the UNIFY Dynamic Anterior Cervical Plate System, a modific… | 2005 |
What descends from it? (10)
3 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 19 years and passes through 2 companies; a new generation was cleared every 2.6 years on median.
- 5 of the 17 ancestors have a recall of any class.
- Of its descendants, K133567 (Globus Medical, Inc., 2014) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K040721.
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. 2012, 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 UNIFYTM 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121049: Unify Dynamic Anterior Cervical Plate System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121049
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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