510(k) · Cleared
Recalled · Class II · 2020Oryx 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 Nov 8, 2019 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 1 other predicate after a 100-day review. Its family tree reaches back 4 generations to 2003. It has been recalled once.
- Decided
- Nov 8, 2019
- Review
- 100 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 4 generations to K031276 (2003). 7 ancestors in all, the oldest K000536 (2000). No later device cites it as a predicate yet.
- Root · 4 generations backK031276 Synthes Anterior Cervical Locking Plate (Aclp) SystemSynthes (Usa) · 2003
- 3 generations backK033844 Synthes Anterior Cervical Compression SystemSynthes (Usa) · 2004
- 2 generations backK050451 Synthes Vectra SystemSynthes Spine Co.Lp · 2005 · Recalled
- 1 generation backK061147 Opteryx Anterior Cervical Plate SystemInnovasis, Inc. · 2006 · Recalled
- This deviceK192049 Oryx Cervical Plate SystemInnovasis, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K031276 | Synthes Anterior Cervical Locking Plate (Aclp) System | Synthes (Usa) | 2003 | — |
| −3 | K033844 | Synthes Anterior Cervical Compression System | Synthes (Usa) | 2004 | — |
| −2 | K050451 | Synthes Vectra System | Synthes Spine Co.Lp | 2005 | 3 |
| −1 | K061147 | Opteryx Anterior Cervical Plate System | Innovasis, Inc. | 2006 | 1 |
| 0 (this device) | K192049 | Oryx Cervical Plate System | Innovasis, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 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? (2)
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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 4…ss 2 Product Code: KWQ Review Panel: Orthopedic Review Team: ISDT Primary Predicte: K030866 Synthes Anterior CSLP System Additional: K061147 Innovasis Opteryx Anterior Cervical Plate System Device D… | 2003 |
| * | K061147 | Opteryx Anterior Cervical Plate SystemSummary page 4…Review Panel: Orthopedic Review Team: ISDT Primary Predicte: K030866 Synthes Anterior CSLP System Additional: K061147 Innovasis Opteryx Anterior Cervical Plate System Device Description: The Oryx Cervical Plate System consists of a number o… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 7, 2020 | Class II | Z-2062-2020 | Process control | Cervical screw caddies have incorrect text markings for the 4.5mm Fixed and Variable rescue screws. The caddy location labeled as "Fixed" should be labeled as "Variable" and the caddy location labeled as "Variable" should be labeled as… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 3 of the 7 ancestors have a recall of any class.
- 41 other devices also cite its predicate K030866.
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 Innovasis Oryx Cervical Plate System is intended for use in anterior cervical fixation for the following indications:
i. Degenerative Disc Disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies),
ii. Spondylolisthesis,
iii. Trauma (i.e., fracture or dislocation)
iv. Spinal stenosis,
v. Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
vi. Tumor,
vii. Pseudoarthrosis; and
viii. Previous failed fusion.
The Innovasis Oryx Cervical Plate System is indicated for stabilizing the cervical spine from C2 to C7.
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/K192049 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192049: Oryx 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/K192049
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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