510(k) · Cleared
ClearedRenovis Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Renovis Surgical Technologies, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 25, 2015 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 2 other predicates after a 51-day review. Its family tree reaches back 5 generations to 1998. 4 later devices descend from it.
- Decided
- Sep 25, 2015
- Review
- 51 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K973854 (1998). 17 ancestors in all, the oldest K792352 (1979). 4 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK973854 Orion Anterior Cervical Plate SystemSofamor Danek USA,Inc. · 1998
- 4 generations backK042235 Orion Anterior Cervical Plating SystemMedtronic Sofamor Danek · 2004
- 3 generations backK042922 Venture Anterior Cervical Plating SystemMedtronic Sofamor Danek, Inc. · 2004
- 2 generations backK061274 Venture Anterior Cervical Plate SystemMedtronic Sofamor Danek · 2006
- 1 generation backK102820 Appliance, Fixation, Spinal Intervertebral BodyAlphatec Spine, Inc. · 2010 · Recalled
- This deviceK152193 Renovis Anterior Cervical Plate SystemRenovis Surgical Technologies, Inc. · 2015
- Descendant · cites it directly · 3 of its ownK231766 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023
- Descendant · 2 generations on · 2 of its ownK243015 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK250486 Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025
- Descendant · 4 generations on · 0 of its ownK261451 ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026
Most influential descendants
Showing 4 of 4 · See all- K231766Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2023 · cites it directly3descendants
- K243015Skyway Anterior Cervical Plate SystemKyocera Medical Technologies, Inc. · 2024 · 2 generations on2descendants
- K250486Skyway Anterior Cervical Plate SystemKyocera Medical Technologies Inc. (KMTI) · 2025 · 3 generations on1descendant
- K261451ZSAlign Cervical Interbody SystemZSFab, Inc. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K973854 | Orion Anterior Cervical Plate System | Sofamor Danek USA,Inc. | 1998 | — |
| −4 | K042235 | Orion Anterior Cervical Plating System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K042922 | Venture Anterior Cervical Plating System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| −2 | K061274 | Venture Anterior Cervical Plate System | Medtronic Sofamor Danek | 2006 | — |
| −1 | K102820 | Appliance, Fixation, Spinal Intervertebral Body | Alphatec Spine, Inc. | 2010 | 2 |
| 0 (this device) | K152193 | Renovis Anterior Cervical Plate System | Renovis Surgical Technologies, Inc. | 2015 | — |
| +1 | K231766 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2023 | — |
| +2 | K243015 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies, Inc. | 2024 | — |
| +3 | K250486 | Skyway Anterior Cervical Plate System | Kyocera Medical Technologies Inc. (KMTI) | 2025 | — |
| +4 | K261451 | ZSAlign Cervical Interbody System | ZSFab, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K030866 | Synthes Anterior CSLP SystemSummary page 4…Device Class: Class II Regulation 21 CFR 888.3060 and Product Code: KWQ Classification panel: Orthopedic C) Predicate: K030866 Synthes Anterior CSLP System D) Device Description The Renovis Anterior Cervical Plate System consists of various shapes and si… | 2003 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 5…thoracic or lumbar spine. F) Substantial Equivalence Comparison The Renovis Anterior Cervical Plate System and predicate devices (K030866 Synthes Anterior CSLP System; K945700 Synthes Anterior Cervical Vertebrae Plate System; K102820 Trestle Luxe Anterior Cervical Plating System, Alphatec Spine) have the… | 1995 |
| * | K102820 | Appliance, Fixation, Spinal Intervertebral BodySummary page 5…arison The Renovis Anterior Cervical Plate System and predicate devices (K030866 Synthes Anterior CSLP System; K945700 Synthes Anterior Cervical Vertebrae Plate System; K102820 Trestle Luxe Anterior Cervical Plating System, Alphatec Spine) have the same intended use/ Indications for Use, are manufactured… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231766 | Skyway Anterior Cervical Plate System | 2023 | 3 |
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 17 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- 3 of the 17 ancestors have a recall of any class.
- Of its descendants, K231766 (Kyocera Medical Technologies Inc. (KMTI), 2023) has gone furthest, with 3 descendants of its own.
- 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. 2015, 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 Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions: * degenerative disc disease(DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * trauma…
Read the full statement (110 words)
The Renovis Anterior Cervical Plate System is intended for anterior screw fixation of the cervical spine (C2-C7). The system is indicated for use in the temporary stabilization of the anterior spine during the development of fusion in patients with the following conditions:
* degenerative disc disease(DDD) (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)
* spinal stenosis
* tumor
* pseudoarthrosis
* failed previous fusion
WARNING: The Renovis Anterior Cervical Plate System is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
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/K152193 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152193: Renovis Anterior 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/K152193
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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