510(k) · Cleared
ClearedAltus Spine 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 Feb 6, 2017 as substantially equivalent to K091396 (Cardo Medical Corp., 2009) and 2 other predicates after a 97-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Feb 6, 2017
- Review
- 97 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K922087 (1992). 34 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 7 generations between
- 3 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
- 2 generations backK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
- 1 generation backK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
- This deviceK163061 Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 0 of its ownK183084 Fuji Cervical Plate SystemAltus Partners, LLC · 2019
Show all 11 generations
- Root · 11 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 10 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 9 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 8 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 7 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 6 generations backK040003 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- 5 generations backK043181 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2004
- 4 generations backK051815 Modification to Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2005
- 3 generations backK062110 Vertebron SCP Cervical Plate SystemVertebron, Inc. · 2006
- 2 generations backK073530 Accin Anterior Cervical Plate SystemAccelerated Innovation, LLC · 2008
- 1 generation backK091396 Cardo Medical Anterior Cervical Plate SystemCardo Medical Corp. · 2009
- This deviceK163061 Altus Spine Cervical Plate SystemAltus Partners, LLC · 2017
Most influential descendants
Showing 1 of 1 · See all- K183084Fuji Cervical Plate SystemAltus Partners, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −10 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −9 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −8 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −7 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −6 | K040003 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| −5 | K043181 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2004 | — |
| −4 | K051815 | Modification to Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2005 | — |
| −3 | K062110 | Vertebron SCP Cervical Plate System | Vertebron, Inc. | 2006 | — |
| −2 | K073530 | Accin Anterior Cervical Plate System | Accelerated Innovation, LLC | 2008 | — |
| −1 | K091396 | Cardo Medical Anterior Cervical Plate System | Cardo Medical Corp. | 2009 | — |
| 0 (this device) | K163061 | Altus Spine Cervical Plate System | Altus Partners, LLC | 2017 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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? (3)
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 |
|---|---|---|---|
| * | K091396 | Cardo Medical Anterior Cervical Plate SystemSummary page 4…RIETARY NAME: Altus Spine Cervical Plate System PRIMARY PREDICATE DEVICE: Cardo Medical Cervical Plate System from Cardo Medical Corporation (K091396) ADDITIONAL PREDICATE Accin Cervical Plate System by Accelerated Innovations, LLC DEVICES: (K073530);… | 2009 |
| * | K073530 | Accin Anterior Cervical Plate SystemSummary page 4…al Corporation (K091396) ADDITIONAL PREDICATE Accin Cervical Plate System by Accelerated Innovations, LLC DEVICES: (K073530); Vertebron SCP Cervical Plate System (K040003) CLASSIFICATION NAME: 21 CFR §888.3060 PRODUCT CODES: KWQ… | 2008 |
| * | K040003 | Vertebron SCP Cervical Plate SystemSummary page 4…396) ADDITIONAL PREDICATE Accin Cervical Plate System by Accelerated Innovations, LLC DEVICES: (K073530); Vertebron SCP Cervical Plate System (K040003) CLASSIFICATION NAME: 21 CFR §888.3060 PRODUCT CODES: KWQ DEVICE CLASS: Class II… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K183084 | Fuji Cervical Plate System | 2019 | 0 |
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 25 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 34 ancestors have a recall of any class.
- Of its descendants, K183084 (Altus Partners, LLC, 2019) has gone furthest, with 0 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. 2017, 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 Altus Spine 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 Altus Spine 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/K163061 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163061: Altus Spine 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/K163061
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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