510(k) · Cleared
ClearedReliance Anterior Cervical Plate System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Reliance Medical Systems, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Sep 5, 2012 as substantially equivalent to K030866 (Synthes (Usa), 2003) and 7 other predicates after a 42-day review. Its family tree reaches back 7 generations to 1992. 3 later devices descend from it.
- Decided
- Sep 5, 2012
- Review
- 42 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 7 generations to K922087 (1992). 40 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK922087 Anterior Cervical Plate SystemSofamor Danek Mfg., Inc. · 1992
- 6 generations backK990005 Spinal Concepts, Inc. (Sci) Anterior Cervical Plate SystemSpinal Concepts, Inc. · 1999 · Recalled
- 5 generations backK000486 Abc Cervical Plating SystemAesculap, Inc. · 2000
- 4 generations backK012184 Blackstone Iii Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2002
- 3 generations backK030595 Blackstone Fusion Anterior Cervical Plating SystemBlackstone Medical, Inc. · 2003
- 2 generations backK050892 Hallmarktm Anterior Cervical Plate SystemBlackstone Medical, Inc. · 2005 · Recalled
- 1 generation backK100614 Hallmark Anterior Cervcial Plate System, Hallmark Five-Level…Blackstone Medical, Inc. · 2010
- This deviceK122216 Reliance Anterior Cervical Plate SystemReliance Medical Systems, LLC · 2012
- Descendant · cites it directly · 2 of its ownK140742 Reliance Anterior Cervical PlateReliance Medical Systems, LLC · 2014
- Descendant · cites it directly · 1 of its ownK221572 VyPlate Anterior Cervical Plate SystemVy Spine, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK260697 VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026
Most influential descendants
Showing 3 of 3 · See all- K140742Reliance Anterior Cervical PlateReliance Medical Systems, LLC · 2014 · cites it directly2descendants
- K221572VyPlate Anterior Cervical Plate SystemVy Spine, LLC · 2022 · cites it directly1descendant
- K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLC · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922087 | Anterior Cervical Plate System | Sofamor Danek Mfg., Inc. | 1992 | — |
| −6 | K990005 | Spinal Concepts, Inc. (Sci) Anterior Cervical Plate System | Spinal Concepts, Inc. | 1999 | 1 |
| −5 | K000486 | Abc Cervical Plating System | Aesculap, Inc. | 2000 | — |
| −4 | K012184 | Blackstone Iii Anterior Cervical Plating System | Blackstone Medical, Inc. | 2002 | — |
| −3 | K030595 | Blackstone Fusion Anterior Cervical Plating System | Blackstone Medical, Inc. | 2003 | — |
| −2 | K050892 | Hallmarktm Anterior Cervical Plate System | Blackstone Medical, Inc. | 2005 | 2 |
| −1 | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical Plates | Blackstone Medical, Inc. | 2010 | — |
| 0 (this device) | K122216 | Reliance Anterior Cervical Plate System | Reliance Medical Systems, LLC | 2012 | — |
| +1 | K140742 | Reliance Anterior Cervical Plate | Reliance Medical Systems, LLC | 2014 | — |
| +1 | K221572 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | 2022 | — |
| +2 | K260697 | VyPlate™ Anterior Cervical Plate System | Vy Spine, LLC | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1997 | 4 | 0 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2022 | 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? (8)
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 1…KWQ. Substantial Equivalence The Reliance Anterior Cervical Plate is substantially equivalent to the legally marketed Synthes Anterior Cervical Vertebral Plate (K030866, K945700), the Interpore Cross C-Tek (K042798), the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plat… | 2003 |
| * | K945700 | Synthes (Usa) Anterior Cervical Vertebrae Plate SystemSummary page 1…WQ. Substantial Equivalence The Reliance Anterior Cervical Plate is substantially equivalent to the legally marketed Synthes Anterior Cervical Vertebral Plate (K030866, K945700), the Interpore Cross C-Tek (K042798), the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plate System… | 1995 |
| * | K042798 | C-Tek C-Trun Anterior Cervical Plate SystemSummary page 1…ance Anterior Cervical Plate is substantially equivalent to the legally marketed Synthes Anterior Cervical Vertebral Plate (K030866, K945700), the Interpore Cross C-Tek (K042798), the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plate System (K100614), Pioneer PAC Anterior Cervi… | 2004 |
| * | K070891 | Altiva Classic Acp SystemSummary page 1…bstantially equivalent to the legally marketed Synthes Anterior Cervical Vertebral Plate (K030866, K945700), the Interpore Cross C-Tek (K042798), the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plate System (K100614), Pioneer PAC Anterior Cervical Plate (K083663), X-Spine Spider… | 2007 |
| * | K100614 | Hallmark Anterior Cervcial Plate System, Hallmark Five-Level Cervical PlatesSummary page 1…vical Vertebral Plate (K030866, K945700), the Interpore Cross C-Tek (K042798), the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plate System (K100614), Pioneer PAC Anterior Cervical Plate (K083663), X-Spine Spider Plate (K052292), and the Aesculap Caspar Plate (K953720). The Rel… | 2010 |
| * | K083663 | PACPSummary page 1…nterpore Cross C-Tek (K042798), the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plate System (K100614), Pioneer PAC Anterior Cervical Plate (K083663), X-Spine Spider Plate (K052292), and the Aesculap Caspar Plate (K953720). The Reliance Anterior Cervical Plate is equivalent to… | 2009 |
| * | K052292 | Spider Cervical Plating (SCP) SystemSummary page 1…the Altiva cerView ACP (K07089 1), the Blackstone Hallmark Anterior Cervical Plate System (K100614), Pioneer PAC Anterior Cervical Plate (K083663), X-Spine Spider Plate (K052292), and the Aesculap Caspar Plate (K953720). The Reliance Anterior Cervical Plate is equivalent to these commercially available dev… | 2005 |
| * | K953720 | Aesculap Caspar Plate & Screw System for Anterior Cervical FusionSummary page 1…ackstone Hallmark Anterior Cervical Plate System (K100614), Pioneer PAC Anterior Cervical Plate (K083663), X-Spine Spider Plate (K052292), and the Aesculap Caspar Plate (K953720). The Reliance Anterior Cervical Plate is equivalent to these commercially available devices in terms of material, intended use,… | 1995 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 20 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 5 of the 40 ancestors have a recall of any class.
- Of its descendants, K140742 (Reliance Medical Systems, LLC, 2014) has gone furthest, with 2 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. 2012, 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 Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include: * instability caused by trauma or fracture; * instability associated with correction of cervical lordosis and kyphosis deformity; * instability associated with pseudoarthosis as a result of…
Read the full statement (144 words)
The Reliance Anterior Cervical Plate System is indicated for stabilization of the anterior cervical spine from C2 to C7 employing unicortical screw fixation at the anterior face of the vertebral bodies. Specific clinical indications for anterior plating include:
* instability caused by trauma or fracture;
* instability associated with correction of cervical lordosis and kyphosis deformity;
* instability associated with pseudoarthosis as a result of previously failed cervical spine surgery;
* instability associated with major reconstructive surgery for primary tumors oirmetastatic malignant tumors of the cervical spine;
* instability associated with single or multiple level corpectomy in advanced degenerative disk disease (defined as discogenic pain with degeneration of the disc confirmed by history and iradiographic studies), spinal canal stenosis and cervical myelopathy.
This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K122216 · printed Nov 6, 2026
Cite this page
510(k) Report. “K122216: Reliance 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/K122216
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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