FDA product code · Orthopedic
KWPAppliance, Fixation, Spinal Interlaminal
Product code KWP covers Appliance, Fixation, Spinal Interlaminal, a Class II device regulated under 21 CFR 888.3050. FDA has cleared 430 devices in this code. Median review time across the 430 most recent decisions is 88 days. openFDA lists 68 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 888.3050
- Review panel
- Orthopedic
- Clearances
- 430
What is happening in KWP right now?
KWP (Appliance, Fixation, Spinal Interlaminal): nothing changed in the six FDA sources we watch.
Checked predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Nothing changed, so there is nothing here — which is the point. We only write when something did.
How many devices has FDA cleared in KWP?
FDA has cleared 430 devices under product code KWP since the 510(k) programme began in 1976.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143278 | LnK Posterior Cervical Fixation System | L&K BIOMED Co., Ltd. | |
| K150753 | OASYS System | Stryker Corporation | |
| K150851 | Sure Lok Mini Posterior Cervical/Upper Thoracic System | Precision Spine, Inc. | |
| K142867 | Reliance Posterior Cervical-Thoracic System | Reliance Medical Systems, LLC | |
| K150254 | Streamline OCT Occipito-Cervico-Thoracic System | Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | |
| K142253 | SOLSTICE OCT System | Life Spine, Inc. | |
| K150229 | SOLSTICE OCT System | Life Spine, Inc. | |
| K143249 | SOLSTICE OCT System | Life Spine, Inc. | |
| K142741 | OASYS System | Stryker Corporation | |
| K142558 | Caspian OCT/MESA Mini/DENALI Mini Spinal System | K2m |
How long does FDA review take for KWP?
The median FDA review time for KWP is 88 days, measured across the 430 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 KWP?
openFDA lists 68 recall records against product code KWP. A recall record covers one firm's corrective action and may span many device lots.
Z-1409-2023Open, ClassifiedMedtronic Sofamor Danek USA, Inc
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1410-2023Open, ClassifiedMedtronic Sofamor Danek USA, Inc
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1411-2023Open, ClassifiedMedtronic Sofamor Danek USA, Inc
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1412-2023Open, ClassifiedMedtronic Sofamor Danek USA, Inc
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Z-1413-2023Open, ClassifiedMedtronic Sofamor Danek USA, Inc
Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws
Showing the 5 most recently initiated of 68. 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 KWP?
MAUDE holds 1,302 adverse-event reports naming product code KWP, 309 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 KWP unusual?
One month sits above KWP's own expected range: 1 March 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 20 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 38 | Insufficient history | No expected range — too little history | |
| 41 | Insufficient history | No expected range — too little history | |
| 27 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 46 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 76 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 22 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 26 | Insufficient history | No expected range — too little history | |
| 35 | Insufficient history | No expected range — too little history | |
| 20 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 62 | Insufficient history | No expected range — too little history | |
| 46 | 1–69 | Within expected (1–69) | |
| 33 | 3–63 | Within expected (3–63) | |
| 71 | 5–70 | Above expected (5–70) | |
| 51 | 17–81 | Within expected (17–81) | |
| 28 | 15–77 | Within expected (15–77) | |
| 27 | 10–75 | Within expected (10–75) | |
| 34 | 9–109 | Within expected (9–109) | |
| 39 | 0–78 | Within expected (0–78) | |
| 32 | 2–81 | Within expected (2–81) | |
| 34 | 0–78 | Within expected (0–78) | |
| 31 | 0–67 | Within expected (0–67) | |
| 52 | 0–73 | Within expected (0–73) | |
| 23 | 7–87 | Within expected (7–87) | |
| 69 | 0–70 | Within expected (0–70) | |
| 47 | 6–92 | Within expected (6–92) |
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 KWP.
What are the predicate devices in KWP?
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 KWP?
Across the 430 most recent decisions, these applicants filed most often in KWP.
| Applicant | Recent clearances |
|---|---|
| Medtronic Sofamor Danek | 25 |
| Medtronic Sofamor Danek, Inc. | 19 |
| Synthes (Usa) | 17 |
| Danek Medical, Inc. | 16 |
| Acromed Corp. | 14 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in KWP files 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 |
|---|---|---|
| Medtronic Sofamor Danek, Inc. | 44 | 2 |
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 KWP
Get an email the morning anything changes in KWP — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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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.