510(k) · Cleared
Recalled · Class II · 2017Opteryx Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innovasis, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Jun 30, 2006 as substantially equivalent to K000536 (Synthes Spine, 2000) and 2 other predicates after a 66-day review. Its family tree reaches back 3 generations to 2003. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 30, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K031276 (2003). 5 ancestors in all, the oldest K000536 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 2 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- 1 generation backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- This deviceK061147 Opteryx Anterior Cervical Plate SystemInnovasis, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK192049 Oryx Cervical Plate SystemInnovasis, Inc. · 2019 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K192049Oryx Cervical Plate SystemInnovasis, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −2 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| −1 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| 0 (this device) | K061147 | Opteryx Anterior Cervical Plate System | Innovasis, Inc. | 2006 | — |
| +1 | K192049 | Oryx Cervical Plate System | Innovasis, Inc. | 2019 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 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 |
|---|---|---|---|
| * | K000536 | Synthes Anterior CSLP SystemSummary page 1…WQ 888.3060 - Spinal intervertebral body fixation Orthosis. Panel code: 87 Substantially Equivalent Devices: - Synthes 'CS)LP' Cervical Spine Locking Plate (K000536), - Theken 'Tether' Anterior Cervical Fixation System (K050451), -… | 2000 |
| * | K050451 | Synthes Vectra SystemSummary page 1…alent Devices: - Synthes 'CS)LP' Cervical Spine Locking Plate (K000536), - Theken 'Tether' Anterior Cervical Fixation System (K050451), - Medtronic 'ephir Anterior Cervical Plate System (K994239), Device Description:… | 2005 |
| * | K994239 | Zephir Anterior Cervical Plate SystemSummary page 1…- Theken 'Tether' Anterior Cervical Fixation System (K050451), - Medtronic 'ephir Anterior Cervical Plate System (K994239), Device Description: The Innovasis 'Opteryx Anterior Cervical Plate System is a 6A1-4V ELI Titanium Alloy… | 2000 |
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 |
|---|---|---|---|
| K192049 | Oryx Cervical Plate System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2017 | Class II | Z-2153-2017 | Error in labeling | Opteryx Variable Rescue Screws are engraved with incorrect (larger) size (16 instead of 14). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K192049 (Innovasis, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 39 other devices also cite its predicate K000536.
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.
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 Innovasis Opteryx TM Cervical Plate System is intended for use in anterior cervical fixation for the following indications: Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (i.e., fracture or dislocation) Spinal stenosis, Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), Tumor, Pseudoarthrosis, and/or…
Read the full statement (82 words)
The Innovasis Opteryx TM Cervical Plate System is intended for use in anterior cervical fixation for the following indications:
Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin
with degeneration of the disc confirmed by history and radiographic studies),
Spondylolisthesis,
Trauma (i.e., fracture or dislocation)
Spinal stenosis,
Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
Tumor,
Pseudoarthrosis, and/or
Previous failed fusion.
The Innovasis Opteryx TM Anterior Cervical Plate System is indicated for stabilizing the
cervical spine from C2 to C7.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061147 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061147: Opteryx 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/K061147
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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