510(k) · Cleared
ClearedInterplate C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rsb Spine, LLC · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Oct 6, 2009 after a 90-day review. The FDA summary names no predicate by number. 424 later devices descend from it.
- Decided
- Oct 6, 2009
- Review
- 90 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
424 later devices descend from it, 4 citing it directly.
- This deviceK092070 Interplate CRsb Spine, LLC · 2009
- Descendant · cites it directly · 405 of its ownK122630 IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012
- Descendant · 2 generations on · 330 of its ownK133494 Chesapeake Spinal SystemK2m, Inc. · 2014
- Descendant · 3 generations on · 315 of its ownK160125 Cascadia Interbody SystemK2m · 2016
- Descendant · 4 generations on · 169 of its ownK162264 Cascadia Interbody SystemK2m, Inc. · 2016
- Descendant · cites it directly · 155 of its ownK142218 Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015
Showing 5 of 424 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 424 · See all- K122630IN:C2 Spinal Fixation SystemSpine Smith Partners L.P. · 2012 · cites it directly405descendants
- K133494Chesapeake Spinal SystemK2m, Inc. · 2014 · 2 generations on330descendants
- K160125Cascadia Interbody SystemK2m · 2016 · 3 generations on315descendants
- K162264Cascadia Interbody SystemK2m, Inc. · 2016 · 4 generations on169descendants
- K142218Coalition AGX Plate and Coalition AGX SpacerGlobus Medical, Inc. · 2015 · cites it directly155descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092070 | Interplate C | Rsb Spine, LLC | 2009 | — |
| +1 | K122630 | IN:C2 Spinal Fixation System | Spine Smith Partners L.P. | 2012 | — |
| +2 | K133494 | Chesapeake Spinal System | K2m, Inc. | 2014 | — |
| +3 | K160125 | Cascadia Interbody System | K2m | 2016 | — |
| +4 | K162264 | Cascadia Interbody System | K2m, Inc. | 2016 | — |
| +1 | K142218 | Coalition AGX Plate and Coalition AGX Spacer | Globus Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 8 | 0 |
| 2016 | 8 | 0 |
| 2017 | 20 | 0 |
| 2018 | 15 | 0 |
| 2019 | 21 | 0 |
| 2020 | 41 | 0 |
| 2021 | 41 | 0 |
| 2022 | 51 | 0 |
| 2023 | 57 | 0 |
| 2024 | 53 | 0 |
| 2025 | 52 | 0 |
| 2026 | 49 | 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?
The FDA summary names no predicate by number.
What descends from it? (424)
See all 4244 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?
- Of its descendants, K122630 (Spine Smith Partners L.P., 2012) has gone furthest, with 405 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. 2009, 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 InterPlateTM C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic…
Read the full statement (198 words)
The InterPlateTM C is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. It is intended for use at one level in the cervical spine, from C3 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is to be used in patients who have had six weeks of non-operative treatment.
In addition, the InterPlateTM C is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
WARNING: The InterPlate TM C is not intended 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/K092070 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092070: Interplate C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092070
Report an extraction error
Are you the manufacturer?
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