510(k) · Cleared
ClearedFuji Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altus Partners, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on May 29, 2019 as substantially equivalent to K163061 (Altus Partners, LLC, 2017) after a 204-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- May 29, 2019
- Review
- 204 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K922087 (1992). 35 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 8 generations between
- 3 generations backK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
- 2 generations backK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
- 1 generation backK163061 Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
- This deviceK183084 Fuji Cervical Plate SystemAltus Partners, LLC · 2019
Show all 12 generations
- Root · 12 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 11 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 10 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 9 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 8 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 7 generations backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- 6 generations backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- 5 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
- 4 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
- 3 generations backK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
- 2 generations backK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
- 1 generation backK163061 Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
- This deviceK183084 Fuji Cervical Plate SystemAltus Partners, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −11 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −10 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −9 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −8 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −7 | K040003 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| −6 | K043181 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| −5 | K051815 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2005 | — |
| −4 | K062110 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2006 | — |
| −3 | K073530 | Accin Anterior Cervical Plate System | Accelerated Innovation, LLC | 2008 | — |
| −2 | K091396 | Cardo Medical Anterior Cervical Plate System | Cardo Medical Corp. | 2009 | — |
| −1 | K163061 | Altus Spine Cervical Plate System | Altus Partners, LLC | 2017 | — |
| 0 (this device) | K183084 | Fuji Cervical Plate System | Altus Partners, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2008 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K163061 | Altus Spine Cervical Plate SystemSummary page 4…9 COMMON NAME: Cervical Plate System PROPRIETARY NAME: Fuji Cervical Plate System PRIMARY PREDICATE DEVICES: Altus Spine Cervical Plate System (K163061) ADDITIONAL PREDICATE DEVICES: N/A CLASSIFICATION NAME: 21 CFR §888.3060 PRODUCT CODES: KWQ… | 2017 |
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 27 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 4 of the 35 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. 2019, 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 Fuji Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine 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), pseudosarthrosis and/or failed previous fusions. The Fuji Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183084 · printed Nov 5, 2026
Cite this page
510(k) Report. “K183084: Fuji 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/K183084
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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