510(k) · Cleared
ClearedASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation 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 Nov 6, 2018 as substantially equivalent to K040721 (Globus Medical, Inc., 2004) and 12 other predicates after a 118-day review. Its family tree reaches back 10 generations to 2000. 4 later devices descend from it.
- Decided
- Nov 6, 2018
- Review
- 118 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 10 generations to K000319 (2000). 153 ancestors in all, the oldest K761228 (1976). 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 6 generations between
- 3 generations backK140678 Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
- 2 generations backK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
- 1 generation backK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- This deviceK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
- Descendant · cites it directly · 2 of its ownK191584 FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019
- Descendant · 2 generations on · 0 of its ownK232256 Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024
- Descendant · cites it directly · 0 of its ownK233735 ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK211205 Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021
Show all 10 generations
- Root · 10 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 9 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 8 generations backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- 7 generations backK033090 Icon Polyaxial Pedicle Screw SystemAlphatec Mfg., Inc. · 2004 · Recalled
- 6 generations backK051286 Zodiac Spinal Fixation SystemAlphatec/Nexmed · 2005
- 5 generations backK093077 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2009
- 4 generations backK100685 Zodiac Polyaxial Spinal Fixation SystemAlphatec Spine, Inc. · 2010
- 3 generations backK140678 Cosmolock Pedicle Screw SystemKalitec Direct, LLC · 2014
- 2 generations backK163471 Kalitec Direct InSePtion™ MIS Fixation SystemKalitec Direct, LLC · 2017
- 1 generation backK180156 SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty…Globus Medical, Inc. · 2018
- This deviceK181846 ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical…Globus Medical, Inc. · 2018
Most influential descendants
Showing 4 of 4 · See all- K191584FORTICO Anterior Cervical Fixation SystemCamber Spine Technologies, LLC · 2019 · cites it directly2descendants
- K232256Alcantara Thoracolumbar Plate SystemCamber Spine Technologies, LLC · 2024 · 2 generations on0descendants
- K233735ADIRA™ Lateral Plate SystemGlobus Medical, Inc. · 2024 · cites it directly0descendants
- K211205Prase-C Anterior Cervical Plate SystemGbs Commonwealth Co., Ltd. · 2021 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −9 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −8 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| −7 | K033090 | Icon Polyaxial Pedicle Screw System | Alphatec Mfg., Inc. | 2004 | 1 |
| −6 | K051286 | Zodiac Spinal Fixation System | Alphatec/Nexmed | 2005 | — |
| −5 | K093077 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2009 | — |
| −4 | K100685 | Zodiac Polyaxial Spinal Fixation System | Alphatec Spine, Inc. | 2010 | — |
| −3 | K140678 | Cosmolock Pedicle Screw System | Kalitec Direct, LLC | 2014 | — |
| −2 | K163471 | Kalitec Direct InSePtion™ MIS Fixation System | Kalitec Direct, LLC | 2017 | — |
| −1 | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | Globus Medical, Inc. | 2018 | — |
| 0 (this device) | K181846 | ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate… | Globus Medical, Inc. | 2018 | — |
| +1 | K191584 | FORTICO Anterior Cervical Fixation System | Camber Spine Technologies, LLC | 2019 | — |
| +2 | K232256 | Alcantara Thoracolumbar Plate System | Camber Spine Technologies, LLC | 2024 | — |
| +1 | K233735 | ADIRA™ Lateral Plate System | Globus Medical, Inc. | 2024 | — |
| +2 | 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 |
|---|---|---|
| 1976 | 1 | 0 |
| 1978 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 1 | 0 |
| 1992 | 5 | 0 |
| 1993 | 4 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 4 | 0 |
| 2003 | 12 | 0 |
| 2004 | 9 | 0 |
| 2005 | 12 | 0 |
| 2006 | 8 | 0 |
| 2007 | 7 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (13)
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 13…PLYMOUTH® PEK SP-Fix® NQW RELIEVE® Regulatory Class: II, Panel Code: 87 Primary Predicate: ASSURE® (K040721) .3DJHRI Additional Predicates:… | 2004 |
| * | K070775 | Modification to: Providence Anterior Cervical Plate SystemSummary page 14…te: ASSURE® (K040721) .3DJHRI Additional Predicates: PROVIDENCE™ (K070775) VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567)… | 2007 |
| * | K081391 | Vip Anterior Cervical Plate SystemSummary page 14…== .3DJHRI Additional Predicates: PROVIDENCE™ (K070775) VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836)… | 2008 |
| * | K092146 | Xtend Anterior Cervical Plate SystemSummary page 14….3DJHRI Additional Predicates: PROVIDENCE™ (K070775) VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108)… | 2009 |
| * | K121049 | Unify Dynamic Anterior Cervical Plate SystemSummary page 14…HRI Additional Predicates: PROVIDENCE™ (K070775) VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092)… | 2012 |
| * | K133567 | Unify (R) Dynamic Anterior Cervical Plate SystemSummary page 14…Additional Predicates: PROVIDENCE™ (K070775) VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092)… | 2014 |
| * | K062836 | Citadel Anterior Lumbar Plate SystemSummary page 14…IDENCE™ (K070775) VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K… | 2006 |
| * | K092108 | Truss Thoracolumbar Plate SystemSummary page 14…VIP® (K081391) XTEND® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K180156) RELIEVE®… | 2009 |
| * | K120092 | Plymouth Thoracolumbar Plate SystemSummary page 14…D® (K092146) UNIFY® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K180156) RELIEVE® (K080664, K180156) Reference Device:… | 2012 |
| * | K102195 | SP-Fix Spinous Process Fixation PlateSummary page 14…® (K121049, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K180156) RELIEVE® (K080664, K180156) Reference Device: MR Compatibility for Intervert… | 2011 |
| * | K132191 | SP-Fix Spinous Process Fixation PlateSummary page 14…9, K133567) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K180156) RELIEVE® (K080664, K180156) Reference Device: MR Compatibility for Intervertebral Fus… | 2013 |
| * | K180156 | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation SystemSummary page 14…7) CITADEL® (K062836) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K180156) RELIEVE® (K080664, K180156) Reference Device: MR Compatibility for Intervertebral Fusion and V… | 2018 |
| * | K080664 | Relieve Laminoplasty Fixation SystemSummary page 14…6) TRUSS® (K092108) PLYMOUTH® (K120092) SP-Fix® (K102195, K132191, K180156) RELIEVE® (K080664, K180156) Reference Device: MR Compatibility for Intervertebral Fusion and Vertebral Body Repla… | 2008 |
| † | K171848 | FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO… | 2017 |
What descends from it? (4)
2 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 18 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 18 of the 153 ancestors have a recall of any class.
- Of its descendants, K191584 (Camber Spine Technologies, LLC, 2019) has gone furthest, with 2 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. 2018, 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 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 fusion, spondylolisthesis, and…
Read the full statement (649 words)
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 fusion, spondylolisthesis, and spinal stenosis.
The PROVIDENCE™ 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 fusion, spondylolisthesis, and spinal stenosis.
The VIP® 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 fusion, spondylolisthesis, and spinal stenosis.
The XTEND® 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 fusion, spondylolisthesis, and spinal stenosis.
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 CITADEL® Anterior Lumbar Plate System is intended for use by an anterior or anterolateral approach in the treatment of lumbar and 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 patient history and radiographic studies), pseudoarthrosis, spondylolysis, spondylolisthesis, scoliosis, kyphosis, lordosis, spinal stenosis, or failed previous spine surgery.
The TRUSS® Thoracolumbar Plate System is intended for use in the treatment of 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 failed previous spine surgery.
The PLYMOUTH® Thoracolumbar Plate System is intended for use in the treatment of 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 failed previous spine surgery.
The SP-Fix® Spinous Process Fixation Plate 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 the 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 SP-Fix® Spinous Process Fixation Plate is intended for use with allograft or autograft bone and is not intended for stand-alone use.
The RELIEVE® Laminoplasty Fixation System is intended for use in the lower cervical and upper thoracic spine (C3-T3) in laminoplasty procedures. The RELIEVE® Laminoplasty Fixation System is used to hold the bone allograft material in place in order to prevent the allograft from expulsion, or impinging the spinal cord.
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/K181846 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181846: ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty 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/K181846
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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