FDA product code · Orthopedic
KWQAppliance, Fixation, Spinal Intervertebral Body
Product code KWQ covers Appliance, Fixation, Spinal Intervertebral Body, a Class II device regulated under 21 CFR 888.3060. FDA has cleared 667 devices in this code, 11 of them in the last 12 months. Median review time across the 667 most recent decisions is 84 days. openFDA lists 214 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3060
- Review panel
- Orthopedic
- Clearances
- 667
What is happening in KWQ right now?
KWQ (Appliance, Fixation, Spinal Intervertebral Body) has four findings, most consequential first. 1 recall opened in the last 12 months and not yet terminated (Class II) (Z-1821-2026). 4 first-time filers in the last 12 months, including Bethesda Medical Devices, LLC and ZheJiang Decans Medical Devices Co., Ltd (K261309, K252776, K254182, K252611). Clearances are running 23% faster — a median 65 days over the last 12 months against 84 days all-time (elapsed calendar days, not FDA review days) (KWQ:review_time:12m). The code is crowded, scoring 94 of 100 — 244 companies hold a clearance here and 11 arrived in the last 12 months (KWQ:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-1821-2026 |
| New entrant | Worth knowing | K261309, K252776, K254182, K252611 |
| Review time | Context | KWQ:review_time:12m |
| Crowding | Context | KWQ:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in KWQ?
FDA has cleared 667 devices under product code KWQ since the 510(k) programme began in 1976, 11 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate System | Bethesda Medical Devices, LLC | |
| K252776 | ARIES Anterior Cervical Plate Systems | ZheJiang Decans Medical Devices Co., Ltd. | |
| K261112 | CastleLoc-P Anterior Cervical Plate System | L&K BIOMED Co., Ltd. | |
| K260570 | corra cervical plating system | Carlsmed, Inc. | |
| K260697 | VyPlate Anterior Cervical Plate System | Vy Spine, LLC | |
| K260015 | ANTERIS Thoracolumbar Plate System | SpineCraft | |
| K251940 | PathLoc Lumbar Plate System | L&K BIOMED Co., Ltd. | |
| K254182 | Aster | Osteonic Co., Ltd. | |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS) | 4Web, Inc. | |
| K252611 | aprevo® cervical plating system | Carlsmed, Inc. |
How long does FDA review take for KWQ?
The median FDA review time for KWQ is 84 days, measured across the 667 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in KWQ?
openFDA lists 214 recall records against product code KWQ. A recall record covers one firm's corrective action and may span many device lots.
Z-1821-2026Open, ClassifiedClariance Inc
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Z-1799-2021TerminatedAlphatec Spine, Inc.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Z-1800-2021TerminatedAlphatec Spine, Inc.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Z-1801-2021TerminatedAlphatec Spine, Inc.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Z-1802-2021TerminatedAlphatec Spine, Inc.
There is a potential for the screw blocking mechanism on the anterior cervical plate system to disassociate intraoperatively/postoperatively or unlock postoperatively.
Showing the 5 most recently initiated of 214. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for KWQ?
MAUDE holds 997 adverse-event reports naming product code KWQ, 177 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in KWQ unusual?
One month sits above KWQ's own expected range: 1 February 2026.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 19 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 49 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 45 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 19 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 78 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 44 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 37 | Insufficient history | No expected range — too little history | |
| 21 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 42 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 22 | 0–63 | Within expected (0–63) | |
| 15 | 0–53 | Within expected (0–53) | |
| 19 | 0–58 | Within expected (0–58) | |
| 29 | 2–43 | Within expected (2–43) | |
| 17 | 5–41 | Within expected (5–41) | |
| 18 | 5–39 | Within expected (5–39) | |
| 22 | 11–54 | Within expected (11–54) | |
| 23 | 6–38 | Within expected (6–38) | |
| 13 | 7–40 | Within expected (7–40) | |
| 18 | 2–38 | Within expected (2–38) | |
| 30 | 1–34 | Within expected (1–34) | |
| 16 | 10–37 | Within expected (10–37) | |
| 16 | 9–40 | Within expected (9–40) | |
| 32 | 5–32 | Above expected (5–32) | |
| 33 | 8–41 | Within expected (8–41) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in KWQ.
Who has entered KWQ in the last year?
4 companies filed in KWQ for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| Bethesda Medical Devices, LLC | K261309 | |
| ZheJiang Decans Medical Devices Co., Ltd. | K252776 | |
| Osteonic Co., Ltd. | K254182 | |
| Carlsmed, Inc. | K252611 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in KWQ?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in KWQ?
Across the 667 most recent decisions, these applicants filed most often in KWQ.
| Applicant | Recent clearances |
|---|---|
| Nuvasive, Inc. | 21 |
| Globus Medical, Inc. | 15 |
| K2m, Inc. | 15 |
| Blackstone Medical, Inc. | 13 |
| Medtronic Sofamor Danek | 13 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
3 companies in KWQ file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| K2M, Inc. | 20 | 3 |
| Medtronic Sofamor Danek, Inc. | 20 | 2 |
| Life Spine, Inc. | 14 | 3 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch KWQ
Get an email the morning anything changes in KWQ — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
Related product codes in Orthopedic
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.